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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00351130 |
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Date of registration:
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16/03/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
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Scientific title:
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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 and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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79 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00351130 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Switzerland
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novatis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion criteria
- 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 end of core study
Exclusion criteria
- Premature discontinuation in the core study or failure to comply with the core study
protocol
- Any patient that the investigator decides should not participate in the extension
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: valsartan
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Drug: amlodipine
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Primary Outcome(s)
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Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks
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Secondary Outcome(s)
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Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks
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Adverse events after 22 weeks
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Secondary ID(s)
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CVAH631B2406E1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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