drugset / Trial / NCT00239538
SMOOTH - Blood Pressure Control in Diabetic/Obese Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telmisartan | Other / unclassified | 80 mg | — |
| Subject | Valsartan | Small molecule | 160 mg | — |
| Background | Hydrochlorothiazide | Unknown | 12.5 mg | — |