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A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg
To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 493 |
| Start date | 2005-01 |
| Completion | 2006-03 |
Conditions
- Hypertension
Interventions
- aliskiren
Primary outcomes
- Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Countries
United States, Germany