Ramipril 10 mg/Day Prevention

Phase 4

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: Ramipril

• Registration Number: NCT01053910
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-07
• Status Verified: 2009-02
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-20
• Last Update Submitted: 2010-01-20
• Study First Posted: 2010-01-22
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1012

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ramipril	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)

Primary Outcome Measures

Name	Time	Method
Number of patient reaching the 10mg/day dose level	30 days after the treatment start
Overall number of adverse events	at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇩 Dhaka, Bangladesh