A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00260923
- Lead Sponsor
- Novartis
- Brief Summary
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 641
Inclusion Criteria
- Male and female outpatients 18 years of age and older
- Patients who are eligible and able to participate in the study
Exclusion Criteria
- Severe hypertension
- History or evidence of a secondary form of hypertension
- History of hypertensive encephalopathy or cerebrovascular accident.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in diastolic blood pressure after 8 weeks
- Secondary Outcome Measures
Name Time Method Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks Change from baseline in systolic blood pressure after 8 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States