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
Phase 1
- Conditions
- Essential hypertension
- Registration Number
- EUCTR2005-001258-26-IE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 Main Objective: To assess the incremental rate in blood pressure control for those patients on valsartan 320 mg/HCTZ 25 mg and amlodipine 5/10 mg or amlodipine 10 mg/HCTZ 25 mg and valsartan 160/320 mg at (Visit 7, week 18) and end of study (Visit 8, week 22);<br> Secondary Objective: To evaluate the overall number of patients who reached BP control on the valsartan compared to the amlodipine treatment strategy at end of study including the core and extension phase<br> To evaluate safety and tolerability, measured by rate of adverse events between baseline (Visit C, week 14) and end of study (Visit 8, week 22)<br> ;Primary end point(s): The primary efficacy variable is the proportion of patients who have completed and reached blood pressure control (<140/90 mmHg) at week 22
- Secondary Outcome Measures
Name Time Method