An 8-week extension to a randomized, double blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipine treatment strategy in achieving blood presure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy
- Conditions
- Essential hypertension
- Registration Number
- EUCTR2005-001258-26-FI
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 224
Inclusion Criteria
1. MSSBP = 140 mm Hg, and/or MSDBP = 90 mm Hg and currently treated with either
valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/ HCTZ 25 mg at Visit C
2. Written informed consent to participate in the extension study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Premature discontinuation in the core study or failure to comply with the core study protocol
2. Any patient that the investigator decides should not participate in the extension study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method