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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) University of Florida |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00241839 |
This study will test the hypothesis that the administration of a xanthine oxidase inhibitor (allopurinol) will prevent thiazide-induced hyperuricemia, which will result in better blood pressure (BP) control in African Americans.
Condition | Intervention | Phase |
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Cardiovascular Diseases Heart Diseases Hypertension |
Drug: Allopurinol Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Uric Acid and Hypertension in African Americans |
Estimated Enrollment: | 220 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Allopurinol
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Drug: Allopurinol
Allopurinol (300 mg/d) given for 8 weeks compared to placebo group. Titrated according to uric acid level.
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B: Placebo Comparator
Placebo would be given as add on to chlorthalidone for 8 weeks.
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Drug: Placebo
Placebo is given as add on for 8 weeks.
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Thiazide diuretics when used in the treatment of hypertension are associated with many metabolic side effects, including hyperuricemia, gout, insulin resistance, and hyperlipidemia. Each of these conditions is already highly prevalent in African Americans. Our hypothesis is that thiazide-induced hyperuricemia decreases the efficacy of thiazides in controlling BP, leads to endothelial dysfunction, and increases the incidence of insulin resistance and impaired glucose tolerance. This hypothesis will be tested in a randomized, double-blind, placebo-controlled clinical trial of 8-week duration in which a total of 220 African American patients with hypertension will be enrolled, randomized, and treated as follows:
The allopurinol (or placebo) dose will be adjusted to achieve serum uric acid levels between 4 and 5.5 mg/dL. All subjects will receive a low-sodium diet. The primary endpoint is reduction in systolic BP. Secondary endpoints measure endothelial function, ambulatory blood pressure, body composition, systemic inflammation, metabolic parameters, oxidant stress, and renal hemodynamics.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Segal S. Mark, MD | 352-846-2692 | segalms@medicine.ufl.edu |
Contact: Richard J. Johnson, MD | johnsrj@medicine.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Richard J. Johnson, MD 352-392-4007 johnsrj@medicine.ufl.edu |
Principal Investigator: | Richard J. Johnson, MD | University of Florida College of Medicine |
Responsible Party: | University of Florida ( Richard J. Johnson, MD ) |
Study ID Numbers: | 332, R01 HL79352 |
Study First Received: | October 17, 2005 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00241839 |
Health Authority: | United States: Federal Government |
Uric Acid Allopurinol Heart Diseases Vascular Diseases Hypertension |
Antimetabolites Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Free Radical Scavengers |
Enzyme Inhibitors Cardiovascular Diseases Antirheumatic Agents Protective Agents Gout Suppressants Pharmacologic Actions |