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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00273299 |
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
Condition | Intervention | Phase |
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Hypertension |
Drug: valsartan plus hydrochlorothiazide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6–Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension |
Estimated Enrollment: | 528 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
Study ID Numbers: | CVAH631D2301 |
Study First Received: | January 4, 2006 |
Last Updated: | December 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00273299 |
Health Authority: | United States: Food and Drug Administration |
hypertension high blood pressure valsartan/hydrochlorozide severe hypertension |
Vascular Diseases Hydrochlorothiazide Valsartan Hypertension |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Sodium Chloride Symporter Inhibitors Physiological Effects of Drugs |
Diuretics Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |