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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00327145 |
This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ
Condition | Intervention | Phase |
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Hypertension |
Drug: valsartan Drug: hydrochlorothiazide Drug: amlodipine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy |
Estimated Enrollment: | 926 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion criteria
Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP
Exclusion criteria
Study ID Numbers: | CVAA489A2401 |
Study First Received: | May 16, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00327145 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HCTZ hypertension valsartan amlodipine |
Calcium, Dietary Vasodilator Agents Sodium Chloride Symporter Inhibitors Diuretics Vascular Diseases Calcium Channel Blockers |
Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Valsartan Amlodipine Hypertension |
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 |