China Medical University Hospital (CMUH) Triapin Listing
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|ClinicalTrials.gov Identifier: NCT00841880|
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : August 27, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Ramipril + Felodipine Drug: Ramipril||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
Drug: Ramipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a day
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 day
5mg once a day
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841880
|Sanofi-Aventis Administrative Office|
|Study Director:||Fern Lim||Sanofi|