drugset / Trial / NCT00239538

SMOOTH - Blood Pressure Control in Diabetic/Obese Patients

NCT00239538

Phase 4 Completed 840 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to demonstrate that telmisartan 80 mg combined with hydrochlorothiazide 12.5 mg (T80/H12.5) is at least as effective and possibly superior to valsartan 160 mg combined with hydrochlorothiazide 12.5 mg (V160/H12.5) in lowering mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval at the end of a 10-week treatment period in mild-to-moderate hypertensive, overweight or obese patients with type 2 diabetes mellitus

Timeline

Start
2003-01
Primary completion
2004-12
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Telmisartan Other / unclassified 80 mg
Subject Valsartan Small molecule 160 mg
Background Hydrochlorothiazide Unknown 12.5 mg