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

Coronary Artery Disease Clinical Trial

— HOPETips  

Official title:

A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099213
• Other study ID #: RAMIP_L_03123
• Secondary ID: U1111-1193-0859
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2008
• Est. completion date: April 23, 2010

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: April 23, 2010
• Est. primary completion date: April 23, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• RAMIPRIL HOE498
Pharmaceutical form:Tablet Route of administration: Oral

Locations

Country	Name	City	State
Indonesia	Sanofi Administrative Office	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total patients with tolerability score Very Good		12 weeks
Primary	Total patients with tolerability score Good		12 weeks
Primary	Total patients with tolerability score Sufficient		12 weeks
Primary	Total patients with tolerability score Insufficient		12 weeks
Primary	Total patients with tolerability score Not Good		12 weeks
Secondary	Number of Adverse Events or Serious Adverse Events reported		12 weeks