A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
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Status:
This study has been completed.
Purpose:
To learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure.
Interventions:
irbesartan
An angiotensin II receptor (AT1 subtype) antagonist and a non-peptide compound
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Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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PS433540
A novel compound designed to achieve blockade of the endothelin and angiotensin receptors significantly reduced ambulatory blood-pressure levels as well as mean seated office systolic and diastolic pressure in patients with hypertension
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Year Started:
2008
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Males or females 18 - 70 years; mean seated SBP ≥ 140 mmHg and < 180 mmHg and mean seated DBP > 90 and < 109 mmHg at two consecutive qualifying visits (Visits 3/3.5 and Visit 4); mean difference in DBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
Women of child-bearing potential (WOCBP) must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year).
Exclusion Criteria
Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases; history of malignancy other than adequately treated basal cell or squamous cell skin cancer; subjects with a history of myocardial infarction or NYHA class II-IV heart failure; subjects with a history of cerebrovascular accident or transient ischemic attack; subjects with clinically significant cardiac conduction defects, including second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication; subjects with hemodynamically significant valvular disease;
subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.
Patient Involvement:
Patients will be randomized into one of 5 arms:
1. Active Comparator Drug: irbesartan 300 mg (2 x 150 mg capsules) once daily for 12 weeks
2: Placebo Comparator Drug: placebo
placebo capsules once daily for 12 weeks
3: Experimental Drug: PS433540
200 mg (2 x 100 mg capsules) once daily for 12 weeks
4: Experimental Drug: PS433540
400 mg (4 x 100 mg capsules) once daily for 12 weeks
5: Experimental Drug: PS433540
800 mg (8 x 100 mg capsules) once daily for 12 weeks
Blood pressure will be followed from baseline for 12 weeks to determine effectiveness of treatment and dose for PS433540.
Primary Outcome:
Change from baseline in mean seated SBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo.
Secondary Outcome:
Change from baseline in mean seated DBP following 12 weeks of treatment with PS433540 200 mg, 400 mg, 800 mg and placebo; percentage of patients treated with each dose of PS433540 who achieved blood pressure control, defined as <140/90 mmHg, after 12 weeks of treatment.
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 1/12/2010
Reviewed on: 01/12/2010.
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