A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 179
- Locations
- 1
- Primary Endpoint
- Total patients with tolerability score Sufficient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: RAMIPRIL HOE498 (Drug)
Outcomes
Primary Outcomes
Total patients with tolerability score Sufficient
Time Frame: 12 weeks
Total patients with tolerability score Very Good
Time Frame: 12 weeks
Total patients with tolerability score Good
Time Frame: 12 weeks
Total patients with tolerability score Insufficient
Time Frame: 12 weeks
Total patients with tolerability score Not Good
Time Frame: 12 weeks
Secondary Outcomes
- Number of Adverse Events or Serious Adverse Events reported(12 weeks)