Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
NCT ID: NCT00687973
Last Updated: 2011-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
393 participants
INTERVENTIONAL
2008-01-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Valsartan/amlodipine 160/10 mg
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Valsartan/amlodipine 80/5 mg tablets
Atenolol/amlodipine 100/10 mg
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Amlodipine 5 mg capsules
Amlodipine 10 mg capsules
Atenolol 50 mg tablets
Atenolol 100 mg tablets
Interventions
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Valsartan/amlodipine 80/5 mg tablets
Amlodipine 5 mg capsules
Amlodipine 10 mg capsules
Atenolol 50 mg tablets
Atenolol 100 mg tablets
Eligibility Criteria
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Inclusion Criteria
* Hypertension defined by MSDBP \> 90 and or MSSBP \> 140 mmHg, MSDBP \> 80 mmHg, or/and MSSBP \> 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
* Written informed consent to participate in the study prior to any study procedures
Exclusion Criteria
* Evidence of a secondary form of hypertension
* Type 1 diabetes mellitus
* History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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2 & 4 rue Lionel Terray BP 308
Rueil-Malmaison, , France
Countries
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Other Identifiers
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CVAA489AFR02
Identifier Type: -
Identifier Source: org_study_id
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