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
- Registration Number
- NCT03099213
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ramipril RAMIPRIL HOE498 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.
- Primary Outcome Measures
Name Time Method Total patients with tolerability score Sufficient 12 weeks Total patients with tolerability score Very Good 12 weeks Total patients with tolerability score Good 12 weeks Total patients with tolerability score Insufficient 12 weeks Total patients with tolerability score Not Good 12 weeks
- Secondary Outcome Measures
Name Time Method Number of Adverse Events or Serious Adverse Events reported 12 weeks
Trial Locations
- Locations (1)
Sanofi Administrative Office
🇮🇩Bali, Indonesia