A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00219076
- Lead Sponsor
- Novartis
- Brief Summary
To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 504
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 6 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in standing diastolic blood pressure after 6 weeks Change from baseline in standing systolic blood pressure after 6 weeks Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks Change from baseline in mean sitting systolic blood pressure after 6 weeks Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States