drugset / Trial / NCT00841880

China Medical University Hospital (CMUH) Triapin Listing

NCT00841880

Phase 4 Completed 49 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-01
Primary completion
2009-09
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Felodipine Small molecule 5 mg
Subject Ramipril Small molecule 5 mg
Subject Ramipril Small molecule 10 mg

Indications