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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00400777 |
Purpose
This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan, hydrochlorothiazide and amlodipine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy of the Combination of Valsartan and Hydrochlorothiazide and Amlodipine in Hypertensive Patients Not Controlled With Valsartan and Hydrochlorothiazide |
| Estimated Enrollment: | 460 |
| Study Start Date: | August 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CVEA489ABR01 |
| Study First Received: | November 15, 2006 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00400777 History of Changes |
| Health Authority: | Brazil: Ministry of Health; United States: Food and Drug Administration |
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Valsartan hydrochlorothiazide amlodipine hypertension high blood pressure |
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Vasodilator Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Calcium Channel Blockers Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Amlodipine Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Valsartan Hypertension |