drugset / Trial / NCT00819104
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.
Timeline
- Start
- 2008-11
- Primary completion
- —
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 2.5 mg | Oral |
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 2.5 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 25 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 50 mg | Oral |