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

NCT ID: NCT03099213

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-01
• Study Completion Date: 2010-04-23

Brief 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).

Detailed Description

The duration of the study period is 8-12 weeks.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

Ramipril

Receiving ramipril with the recommended initial dose of 2.5 mg once daily; depending on the tolerability, the dose should be gradually increased. The increase should be implemented by doubling the dose after one to two weeks. Three or four weeks later, the dose should be doubled again up to the usual maintenance dose of 10 mg once daily.

Group Type: EXPERIMENTAL

RAMIPRIL HOE498

Intervention Type: DRUG

Pharmaceutical form:Tablet Route of administration: Oral

Interventions

RAMIPRIL HOE498

Pharmaceutical form:Tablet Route of administration: Oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi Administrative Office

Bali, , Indonesia

Countries

Indonesia

Other Identifiers

U1111-1193-0859

Identifier Type: OTHER

Identifier Source: secondary_id

RAMIP_L_03123

Identifier Type: -

Identifier Source: org_study_id