A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
Overview
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.
Full Title of Study: “A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2005
Interventions
- Drug: valsartan + amlodipine
Clinical Trial Outcome Measures
Primary Measures
- Adverse events and serious adverse events at each study visit for 6 or 12 months
Secondary Measures
- 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
- Hematology and blood chemistry after 6 or 12 months
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Investigator Details
- Lead Sponsor
- Novartis
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
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