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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: |
NCT00409851 |
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Date of registration:
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07/12/2006 |
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Primary sponsor: |
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Public title:
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One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension
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Scientific title:
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A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients. |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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1293 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00409851 |
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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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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United States
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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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Sponsor GmbH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- SUCCESSFUL COMPLETION OF VAA489A2201 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
VAA489A2201 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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Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.
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Secondary Outcome(s)
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Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough
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Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough
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Sitting and standing pulse
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Secondary ID(s)
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CVAA489A2201E1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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