A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People "APOLLO"

Terminated

Phase 3 Results

Update History

10 Apr '14
The Summary of Purpose was updated.
New
This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.
Old
This study will provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a CCB) in elderly individuals (≥ 65 years) with SBP 130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive and cognitive function.
The description was updated.
New
This was 2x2 factorial design study with 2 strata. As per protocol, the first co- Primary analysis as well as secondary analysis were aliskiren based regimen vs non-aliskiren based regimen. All aliskiren based arm were combined into the aliskiren based regimen and all non-aliskiren based arms were combined into non-aliskiren based regimen.
Old
None.
The eligibility criteria were updated.
New
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing - Diabetes mellitus: High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to Aliskiren, Amlodipine or Hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker. Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
Old
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
A location was updated in Birmingham.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Los Angeles.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Northridge.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Sylmar.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Tucker.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pocatello.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Haverhill.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in St. Louis.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Westfiled.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Winston-Salem.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Portland.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Falls Church.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Marshfield.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Milwaukee.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ciudad Autonoma de Bs As.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Coronel Suarez.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Jenin.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Mar del Plata.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Merlo.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Quilmes.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in San Nicolas.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Cipolletti.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Tucuman.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Rosario.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Venado Tuerto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Buenos Aires.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Buenos Aires.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Buenos Aires.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Buenos Aires.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Cordoba.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Salta.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Santa Fe.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Belo Horizonte.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Uberaba.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Campina Grande do Sul.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Porto Alegre.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Campinas.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Marilia.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Sao Jose do Rio Preto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in São Paulo.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Votuporanga.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Calgary.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Edmonton.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Coquitlam.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Winnipeg.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in St. John's.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Brampton.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Hamilton.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Hamilton.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Hamilton.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in London.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Markham.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Missisauga.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Newmarket.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Niagara Falls.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in North York.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ottawa.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ottawa.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in St Catherines.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Toronto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Toronto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Toronto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Lévis.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Montreal.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Montreal.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Sainte Foy.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Sainte-Foy.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in St.Gorges de Beauce.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Terrebonne.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Saskatoon.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Quebec.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Temuco.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Vista Del Mar.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Temuca.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Osorno.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Santiago.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Barranquilla.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Cartagena.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Manizoles.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bogota.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pereira.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Floridablanca.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Armenia.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Baranquilla.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Barranquilla.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bogotá.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bogotá.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Cali.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Cartegena.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Espinal.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Monteria.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pasto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Beroun.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Brandys nad Labem.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Novy Jicin.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Prague 4.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Prague 6.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Praha 9.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Uherske Hradiste.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Usti nad Orlici.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Berlin.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Frankfurt.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Melsungen.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Nuernberg.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Wiesbaden.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Witten.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Budapest.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Budapest.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Gyongyos.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Kaposvar.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Komarom.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Mosonmagyarovar.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pecs.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Sopron.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Szentes.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Veszprem.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Adoni.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Adoni.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Hyderabad.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Visakhapatnam.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ahmedabad.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ahmedabad.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bangalore.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bangalore.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Belgaum.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bengaluru.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Nagpur.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Nagpur.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Nagpur.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pune.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Wardha.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Jalandhar.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ludhiana.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bikaner.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Tiruvannamalai.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Trichy.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Lucknow.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Chennai.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Hyderabad.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Mumbai.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Nagpur.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Trichy.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Gorey.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ballinsloe.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Galway.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Givatayim.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Haifa.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Safed.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Alor Setar.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Kota Bahru.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Kota Bharu.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Kuantan.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Batu Caves.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Kuala Lumpur.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Kuala Lumpur.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Breda.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Eindhoven.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Groningen.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Leiderdorp.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Rotterdam.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Velp.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Zoetermeer.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Dasmarinas.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Laoag City.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Quezon City.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Binan City.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Manila.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Manila.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pasig City.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Quezon City.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Paarl.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Bloemfontein.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Durban.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Pretoria.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Valencia.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Ferrol.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Madrid.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Puerto de Sagunto.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Dalby.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Goteborg.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Göteborg.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Malmö.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Rättvik.
New
The overall status was removed for Novartis Investigative Site.
A location was updated in Stockholm.
New
The overall status was removed for Novartis Investigative Site.
4 Sep '13
The eligibility criteria were updated.
New
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
Old
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintigram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
10 Jul '12
The eligibility criteria were updated.
New
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintigram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
Old
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
A location was updated in Portland.
New
The overall status was removed for Investigative Site.
A location was updated in Ciudad de Autonoma de Buenos Aires.
New
The overall status was removed for Investigative Site.
A location was updated in São José do Rio Preto.
New
The overall status was removed for Investigative Site.
A location was updated in Toronto.
New
The overall status was removed for Investigative Site.
A location was updated in Osorno.
New
The overall status was removed for Investigative Site.
A location was updated in Barranquilla.
New
The overall status was removed for Investigative Site.
A location was updated in Prague.
New
The overall status was removed for Investigative Site.
A location was updated in Erlangen.
New
The overall status was removed for Investigative Site.
A location was updated in Budapest.
New
The overall status was removed for Investigative Site.
A location was updated in Mumbai.
New
The overall status was removed for Investigative Site.
A location was updated in Galway.
New
The overall status was removed for Investigative Site.
A location was updated in Batu caves.
New
The overall status was removed for Investigative Site.
A location was updated in Leiderdorp.
New
The overall status was removed for Investigative Site.
A location was updated in Quezon City.
New
The overall status was removed for Investigative Site.
A location was updated in Moscow.
New
The overall status was removed for Investigative Sites.
A location was updated in Cape Town.
New
The overall status was removed for Investigative Site.
A location was updated in Valencia.
New
The overall status was removed for Investigative Site.
A location was updated in Stockholm.
New
The overall status was removed for Investigative Site.
A location was updated in Istanbul.
New
The overall status was removed for Investigative Site.
A location was updated in Kyiv.
New
The overall status was removed for Investigative Site.
6 Oct '11
The Summary of Purpose was updated.
New
This study will provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a CCB) in elderly individuals (≥ 65 years) with SBP 130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive and cognitive function.
Old
This study will provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a CCB) in elderly individuals (? 65 years) with SBP 130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive and cognitive function.
The eligibility criteria were updated.
New
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ≥ 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ≤ 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ≥ 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ≥ 0.90 in women and ≥ 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ≥ 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ≤ 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ≤ 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ≥ 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
Old
Inclusion Criteria: Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3): 1. Men and women aged ? 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease - Previous myocardial infarction or - Stable angina or unstable angina with documented multi-vessel coronary artery disease, > 50% stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or - Multi-vessel PCI, or - Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA < 1 year before informed consent Peripheral artery disease - Previous limb bypass surgery or percutaneous transluminal angioplasty, or - Previous limb or foot amputation, or - History of intermittent claudication, with an ankle:arm BP ratio ? 0.80 on at least one side, or significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage 2. Men and women aged ? 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention): - History of dyslipidemia, defined as LDL cholesterol > 3.5 mmol/L (135 mg/dL) or HDL< 1.3 mmol/L (50 mg/dL) in women or < 1.0 mmol/L (39 mg/dL) in men or total cholesterol/HDL ratio > 5 - History of current or recent smoking (regular tobacco use within 5 years) - Abdominal adiposity defined as waist/hip ratio ? 0.90 in women and ? 0.95 in men - History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol/L [101 to 124 mg/dL]), or impaired glucose tolerance (IGT - fasting plasma glucose < 7 mmol/L [126 mg/dL] but 2 hour glucose 7.8 to 11.0 mmol/L [140 to 198 mg/dL]) or type 2 diabetes - Renal dysfunction: eGFR< 60 ml/min/1.73m2 but > 30 ml/min/1.73m2 (MDRD formula) and/or microalbuminurea/macroalbuminurea - Clinical evidence of left ventricular hypertrophy 3. Men and women aged ? 70 years if they do not have any of the above (primary prevention) Exclusion Criteria: 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and/or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure ? 160 mmHg and/or diastolic blood pressure ? 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke < 3 months or TIA ? 7 days before informed consent, acute coronary syndrome < 1 months before informed consent 7. Planned cardiac surgery or angioplasty < 3 months after informed consent or having had the procedure < 3 months before informed consent 8. Severe renal impairment eGFR ? 30 ml/min/1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium ? 5.3 mmol/L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST > 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR < 60 ml/min/1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures