Ramipril 10 mg/Day Prevention

NCT ID: NCT01053910

Last Updated: 2010-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1012 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31

Brief Summary

The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.

Conditions

Atherosclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ramipril

Duration of treatment: 2 months 7 first days: 1.25mg once daily in patients with stable heart failure and 7 days 2.5mg once daily or 14 first days:2.5mg once daily in patients without heart failure for 14 more days:5mg once daily maintenance therapy for 1 month: 10 mg (5mg, 2 tablets)

Group Type: EXPERIMENTAL

Ramipril

Intervention Type: DRUG

tablet of Ramipril once daily

Interventions

Ramipril

tablet of Ramipril once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of coronary artery disease,
• Stroke
• Stable heart failure
• Peripheral vascular disease, or diabetes with at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low high-density lipoprotein cholesterol levels, cigarette smoking, or documented microalbuminuria).

Exclusion Criteria

• Non stabilized or NYHA grade IV heart failure patients
• Hemodynamically significant primary valvular or outflow tract obstruction (eg. mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)
• Constrictive pericarditis.
• Complex congenital heart disease.
• Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic cardiac arrhythmias including ventricular tachycardia are not an exclusion criterion).
• Planned cardiac surgery or angioplasty within 3 months (patient may be reconsidered for the trial after the procedure).
• Cor pulmonale.
• Heart transplant recipient.
• Significant renal disease defined as:

• Renal artery stenosis;
• Creatine clearance <0.6 ml/second or serum creatinine≥ 200 mEq/L (≥2.26 mg/dl)
• Overt nephropathy: ≥1 plus proteinuria on dipstick or urinary albumin excretion > 200 micrograms/minute (300 mg/24 hrs)
• Hyperkalemia; K>5.5 mEq/L.
• Patient is simultaneously taking another experimental drug.

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Rezaul Farid Khan, Medical Director

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

HOE498_4099

Identifier Type: -

Identifier Source: org_study_id