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A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients
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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 49 |
| Start date | 2009-01 |
| Completion | 2009-09 |
Conditions
- Hypertension
Interventions
- Ramipril + Felodipine
- Ramipril
- Ramipril
Primary outcomes
- Seated SBP at office — After 8-week treatment
Countries
Taiwan