A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00219115
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in mean sitting diastolic blood pressure after 8 weeks
- Secondary Outcome Measures
Name Time Method Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8 Change from baseline in mean sitting systolic blood pressure after 8 weeks Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8 Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States
Novartis Pharmaceuticals🇺🇸East Hanover, New Jersey, United States