Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension
Summary
The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline. The secondary objectives are: * To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24 * To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24 * To compare the difference in mean SBP evaluated by HBPM at week 16 * To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24 * To determine the incidence and severity of adverse events
Timeline
- Start
- 2007-07
- Primary completion
- 2010-01
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irbesartan | Small molecule | 150 mg | — |
| Subject | Irbesartan | Small molecule | 300 mg | — |
| Comparator | Valsartan | Small molecule | 80 mg | — |
| Comparator | Valsartan | Small molecule | 160 mg | — |
| Background | Hydrochlorothiazide | Unknown | 12.5 mg | Oral |