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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00170976 |
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Date of registration:
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10/09/2005 |
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Primary sponsor: |
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Public title:
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A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
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Scientific title:
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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 |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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403 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00170976 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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 + amlodipine
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Primary Outcome(s)
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Adverse events and serious adverse events at each study visit for 6 or 12 months
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Secondary Outcome(s)
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Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
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Change from baseline in sitting and standing pulse after 6 or 12 months
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Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
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Change from baseline in systolic blood pressure from baseline after 6 or 12 months
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Hematology and blood chemistry after 6 or 12 months
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Secondary ID(s)
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CVAA489A2307E1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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