An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event

• Status: Completed
• Trial end date: 2010-04-23
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.

Secondary Objectives:

• To document drug safety at 12-week of treatment in terms of number of Adverse Drug Reaction or Serious Adverse Drug Reaction reported.

• To describe the population treated as per the HOPE study indication in current clinical practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant treatments patterns).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Ramipril

Criteria

Inclusion criteria :

• Man or woman, age 55 years old or more.

• Presence of a high risk of developing a major cardiovascular event, defined as at least one of the following underlying conditions:

• Clinical evidence of coronary artery disease (examples: previous myocardial infarction [MI], positive stress test or significant stenosis at coronary angiography, previous Percutaneous Trans-Luminal Coronary Angioplasty [PTCA], previous Coronary Arterial Bypass Grafting [CABG]);

• Clinical evidence of peripheral vascular disease (examples: history of intermittent claudication with positive Doppler or angiography, previous limb bypass surgery, previous percutaneous trans-luminal angioplasty, previous limb or foot amputation);

• Previous stroke;

• Diabetes (insulin-dependent or non-insulin dependent) with at least one of the following cardiovascular risk factors:

• hypertension (blood pressure [BP] >140/90 mmHg, or patients on antihypertensive treatment);

• hypercholesterolemia (total cholesterol > 5.2 mmol/L [>200 mg/dL]);

• low HDL cholesterol (< 0.9 mmol/L [<3.5 mg/dL]);

• current cigarette smoking;

• documented microalbuminuria (30-300 mg/24 hours);

• Evidence of previous vascular disease.

Exclusion criteria:

• Patients with contraindications to ramipril use (as per the local Ramipril Product Information)

• hypersensitivity

• pregnancy, lactation

• bilateral renal stenosis

• Patients with clinically relevant concomitant disease that could compromise the patient's safety or follow up.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.