Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome
Summary
Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium channel blockers are not well defined. This study will compare the efficacy of RAS inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing 2hour post prandial glucose compared to RAS inhibitors/diuretics.
Timeline
- Start
- 2009-04
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | 5 mg | — |
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | — |
| Subject | Telmisartan | Other / unclassified | 40 mg | — |
| Subject | Telmisartan | Other / unclassified | 80 mg | — |
| Comparator | Valsartan | Small molecule | 80 mg | — |
| Comparator | Valsartan | Small molecule | 160 mg | — |