China Medical University Hospital (CMUH) Triapin Listing
- Registration Number
- NCT00841880
- Lead Sponsor
- Sanofi
- Brief Summary
The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.
To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP\<140mmHg and/or DBP\<90mmHg) and as SBP \< 130 mmHg and /or DBP \< 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score \> 10%.
To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.
To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ramipril + Felodipine 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine 1 Ramipril 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine 2 Ramipril 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg
- Primary Outcome Measures
Name Time Method Seated SBP at office After 8-week treatment
- Secondary Outcome Measures
Name Time Method Seated DBP at office After 4 and 8-week treatment Seated SBP at office After 4-week treatment Response rate After 4 and 8-week treatment BP controlled rate After 4 and 8-week treatment
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇳Taipei, Taiwan