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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00219102 |
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide
Condition | Intervention | Phase |
---|---|---|
Hypertension Diabetes |
Drug: aliskiren |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg |
Estimated Enrollment: | 336 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Other protocol-defined exclusion criteria may apply.
Study ID Numbers: | CSPP100A2310 |
Study First Received: | September 12, 2005 |
Last Updated: | January 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00219102 |
Health Authority: | United States: Food and Drug Administration |
Hypertension, diabetes, aliskiren, |
blood pressure, valsartan, hydrochlorothiazide |
Metabolic Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Metabolic disorder Glucose Metabolism Disorders 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 |