Back to results

Ramipril 10 mg/Day Prevention

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 4

Locations

Bangladesh

Study Type

Interventional

Intervention

Ramipril

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ramipril

Arm Description

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)

Outcomes

Primary Outcome Measures

Number of patient reaching the 10mg/day dose level

Overall number of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT01053910

First Posted

January 14, 2010

Last Updated

January 20, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01053910

Brief Title

Ramipril 10 mg/Day Prevention

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

July 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1012 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ramipril

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ramipril

Intervention Description

tablet of Ramipril once daily

Primary Outcome Measure Information:

Title

Number of patient reaching the 10mg/day dose level

Time Frame

30 days after the treatment start

Title

Overall number of adverse events

Time Frame

at day 7 (visit 2), day 15 (visit 3), day 30 (visit 4), day 45 (visit 5) and day 60 (final visit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rezaul Farid Khan, Medical Director

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Dhaka

Country

Bangladesh

12. IPD Sharing Statement

Learn more about this trial

Ramipril 10 mg/Day Prevention

We'll reach out to this number within 24 hrs