Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.

Completed

Phase 4 Results

Trial Description

The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint.
Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.

Conditions

Interventions

Trial Design

  • Purpose: Prevention
  • Intervention: Parallel Assignment

Patient Involvement

Eligible patients will be randomized to receive either ramipril, telmisartin, or a combination of the two. Patients will be followed for 4-6 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Combined incidence of cardiovascular death, stroke, acute myocardial infarction (MI), and hospitalization for CHF (congestive heart failure).
Secondary Newly diagnosed CHF, revascularisation procedures, newly diagnosed diabetes, cognitive decline/dementia, nephropathy, unstable/worsening angina, transient ischemic attack, no-CV death.
Primary ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure 56 months
Primary TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure 56 months
Secondary ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke 56 months
Secondary ONTARGET. Cardiovascular Death 56 months
Secondary ONTARGET. Non-fatal Myocardial Infarction 56 months
Secondary ONTARGET. Non-fatal Stroke 56 months
Secondary ONTARGET. Hospitalization for Congestive Heart Failure 56 months
Secondary ONTARGET. Newly Diagnosed Congestive Heart Failure 56 months
Secondary ONTARGET. Cardiovascular Revascularization Procedure 56 months
Secondary ONTARGET. Newly Diagnosed Diabetes 56 months
Secondary ONTARGET. Cognitive Decline 56 months
Secondary ONTARGET. New Onset of Atrial Fibrillation 56 months
Secondary TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke 56 months
Secondary TRANSCEND. Cardiovascular Death 56 months
Secondary TRANSCEND. Non-fatal Myocardial Infarction 56 months
Secondary TRANSCEND. Non-fatal Stroke 56 months
Secondary TRANSCEND. Hospitalization for Congestive Heart Failure 56 months
Secondary TRANSCEND. Newly Diagnosed Congestive Heart Failure 56 months
Secondary TRANSCEND. Cardiovascular Revascularization Procedure 56 months
Secondary TRANSCEND. Newly Diagnosed Diabetes 56 months
Secondary TRANSCEND. Cognitive Decline 56 months
Secondary TRANSCEND. New Onset of Atrial Fibrillation 56 months
Primary ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients 56 months No
Secondary ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients 56 months No
Secondary ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients 56 months No
Secondary ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients 56 months No
Secondary ONTARGET. Doubling of Serum Creatinine 56 months No
Secondary ONTARGET. Progression to ESRD 56 months No
Secondary ONTARGET. New Microalbuminuria 56 months No
Secondary ONTARGET. New Macroalbuminuria 56 months No
Secondary ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria 56 months No
Secondary ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria 56 months No
Secondary TRANSCEND. Doubling of Serum Creatinine 56 months No
Secondary TRANSCEND. Progression to ESRD 56 months No
Secondary TRANSCEND. New Microalbuminuria 56 months No
Secondary TRANSCEND. New Macroalbuminuria 56 months No
Secondary TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria 56 months No
Secondary TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria 56 months No

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