A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
Phase 3
Completed
- Conditions
- HYPERTENSION
- Registration Number
- NCT00170976
- Lead Sponsor
- Novartis
- Brief Summary
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
Inclusion Criteria
- SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
- VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg
Exclusion Criteria
- PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events and serious adverse events at each study visit for 6 or 12 months
- Secondary Outcome Measures
Name Time Method Hematology and blood chemistry after 6 or 12 months Change from baseline in diastolic blood pressure from baseline after 6 or 12 months Change from baseline in systolic blood pressure from baseline after 6 or 12 months Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months Change from baseline in sitting and standing pulse after 6 or 12 months
Trial Locations
- Locations (2)
Sites in germany
🇩🇪Multiple Locations, Germany
Novartis Pharmaceuticals
🇨🇭Basel, Switzerland