drugset / Trial / NCT00950066
Irbesartan and Amlodipine Combination in Controlling Blood Pressure
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo. The secondary objectives are: * to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo. * to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-01
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | 5 mg | Oral |
| Comparator | Irbesartan | Small molecule | 150 mg | Oral |
| Comparator | Irbesartan | Small molecule | 300 mg | Oral |