drugset / Trial / NCT00437645
Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[msSBP\] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.
Timeline
- Start
- 2007-01
- Primary completion
- 2007-11
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 10 mg | Oral |
| Subject | Valsartan | Small molecule | 160 mg | Oral |