Back to resultsAn 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 (HOPETips)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
RAMIPRIL HOE498
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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.
Sites / Locations
- Sanofi Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ramipril
Arm Description
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.
Outcomes
Primary Outcome Measures
Total patients with tolerability score Very Good
Total patients with tolerability score Good
Total patients with tolerability score Sufficient
Total patients with tolerability score Insufficient
Total patients with tolerability score Not Good
Secondary Outcome Measures
Number of Adverse Events or Serious Adverse Events reported
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03099213
Brief Title
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
Acronym
HOPETips
Official Title
A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2008 (undefined)
Primary Completion Date
April 23, 2010 (Actual)
Study Completion Date
April 23, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramipril
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RAMIPRIL HOE498
Intervention Description
Pharmaceutical form:Tablet Route of administration: Oral
Primary Outcome Measure Information:
Title
Total patients with tolerability score Very Good
Time Frame
12 weeks
Title
Total patients with tolerability score Good
Time Frame
12 weeks
Title
Total patients with tolerability score Sufficient
Time Frame
12 weeks
Title
Total patients with tolerability score Insufficient
Time Frame
12 weeks
Title
Total patients with tolerability score Not Good
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Adverse Events or Serious Adverse Events reported
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi Administrative Office
City
Bali
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
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
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