China Medical University Hospital (CMUH) Triapin Listing
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients|
- Seated SBP at office [ Time Frame: After 8-week treatment ]
- Seated DBP at office [ Time Frame: After 4 and 8-week treatment ]
- Seated SBP at office [ Time Frame: After 4-week treatment ]
- Response rate [ Time Frame: After 4 and 8-week treatment ]
- BP controlled rate [ Time Frame: After 4 and 8-week treatment ]
|Study Start Date:||January 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
Drug: Ramipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a dayDrug: Ramipril
5mg once a day
Active Comparator: 2
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg
10 mg once a dayDrug: Ramipril
5mg once a day
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841880
|Sanofi-Aventis Administrative Office|
|Study Director:||Fern Lim||Sanofi|