Uric Acid and Hypertension in African Americans

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Diseases, Heart Diseases, Hypertension

In brief

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.

Key facts

Study ID

NCT00241839

Run by

University of Florida

People needed

150

Starts

2005-08-01

Expected to finish

2011-05-01

Last updated by the study team

2013-07-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African American (including black individuals born in the Caribbean, Africa, Canada, etc.)
• Are either untreated with any antihypertensive agent, with an average sitting clinic BP of between 140/90 and 159/99 mm Hg OR subjects with hypertension controlled (i.e. BP less than 140/90) or no higher than stage 1 hypertension (i.e., less than 160/100) on a single antihypertensive agent or two antihypertensive agents (individuals on fixed dose ARB-diuretic or ACEI-diuretic combinations will also be considered as being on monotherapy for purposes of the study. Individuals on beta blockade or calcium channel blockade for coronary artery disease and/or arrhythmia will not be eligible for the study)
• Random spot urine protein/creatinine ratio of less than 0.5 (approximates a 24-hour urinary protein excretion of 500 mg/day)
• Calculated MDRD GFR of greater than or equal to 60 ml/min/1.73/m\^2
• No allopurinol or probenecid intake for at least one month prior to study entry
• Willing and able to cooperate with study procedures
• Willing to travel to the GCRC at Shands Hospital for overnight inpatient stays on two separate occasions

You may not qualify if…

• History of malignant or accelerated hypertension
• Confirmed total white cell count of less than 2,500/mm\^3, anemia, or thrombocytopenia
• Known history of liver disease
• Known secondary cause of hypertension
• Known presence of diabetes or fasting blood glucose greater than or equal to 126 mg/dL
• History of heart failure, acute myocardial infarction, or stroke or on a β-blocker or calcium channel blocker for cardiovascular indications other than for lowering blood pressure
• Abnormal EKG requiring medical intervention
• History of clinical or renal biopsy or evidence of renal parenchymal disease
• Acute gout attack within 2 weeks of study entry
• History of drug abuse in the last 2 years, including narcotics, cocaine, or alcohol (greater than 21 drinks/week)
• Arm circumference of greater than 52 cm, which precludes measurement with a 'thigh' BP cuff
• History of a reaction to allopurinol or chlorthalidone
• Pregnant or planning to become pregnant during the study, or breastfeeding
• History of noncompliance, are unable to comply with the study requirements, or who are currently participating in another study
• Not fasting prior to obtaining screening laboratory data. If a participant has clearly not fasted, we will exclude those individuals with casual blood glucose levels of greater than or equal to 200 mg/dL. In the event that a fasting blood sugar exceeds 126 mg/dL, it will be reconfirmed on a blood glucose measurement obtained on a subsequent day, per American Diabetes Association criteria

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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