Ramipril 10 mg/Day Prevention

Atherosclerosis Clinical Trial

Official title:

A Multicentre Open, Non Comparative Study of the Safety of Ramipril (Tritace) 10 mg/Day in Prevention of Cardiovascular Events in High-risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053910
• Other study ID #: HOE498_4099
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2010
• Last updated: January 20, 2010
• Start date: October 2003

Study information

• Verified date: February 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh:Ministry of Health & Family Welfarer
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Ramipril
tablet of Ramipril once daily

Locations

Country	Name	City	State
Bangladesh	Sanofi-Aventis Administrative Office	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient reaching the 10mg/day dose level		30 days after the treatment start	No
Primary	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)	No