drugset / Trial / NCT01819220

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

NCT01819220

Phase 4 Completed 16 enrolled Yonsei University
RandomizedParallel-groupSingle-blindTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications