CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Allopurinol +3 moredrug
Likely dose
Allopurinol 300 mg daily, titrated to 600 mg if serum uric acid >5.5 mg/dL after 2 weeksAI-extracted
Key inclusion· 5
  • African American ancestry (including those born in Caribbean, Africa, Canada, etc.)
  • Untreated hypertension with average sitting BP 140/90–159/99 mmHg, OR controlled BP (<140/90) or stage 1 hypertension (<160/100) on 1-2 antihypertensives (but not beta-blockers or calcium channel blockers for cardiovascular indications)
  • Spot urine protein/creatinine ratio <0.5 (≈500 mg/day urinary protein)
  • eGFR ≥60 mL/min/1.73 m² by MDRD equation
Key exclusion· 12
  • History of malignant or accelerated hypertension
  • WBC <2,500/mm³, anemia, or thrombocytopenia
  • Known liver disease
  • Known secondary cause of hypertension

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00241839
NCT00241839Phase 3Completed

Uric Acid and Hypertension in African Americans

University of Florida·interventional·Posted Oct 19, 2005·Updated Jul 26, 2013

In Brief

A Phase 3 clinical trial evaluating Allopurinol, Placebo, and 2 other interventions for Cardiovascular Diseases and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2005
Enrollment StartAug 1, 2005
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.7 years ago

Interventions

Allopurinoldrug

Allopurinol (300 mg capsule) was given for 8-10 weeks compared to placebo group after initial baseline testing. After two weeks on the Allopurinol, a serum uric acid level was obtained. If the uric acid level was greater than 5.5, the Allopurinol dosage was increased to 600mg (two 300 mg capsules)for the duration of the trial, 6-8 weeks.

Placebodrug

Placebo capsule (matched in appearance for Allopurinol and labeled 300mg) was given for 8-10 weeks compared to the Allopurinol group after initial baseline testing. After two weeks on the placebo, a serum uric acid level was obtained. If the uric acid level was greater than 5.5, the placebo dosage was increased to 600mg (two 300 mg capsules)for the duration of the study, 6-8 weeks.

Chlorthalidonedrug

Chlorthalidone 25 mg was given daily for 5 weeks before baseline visit for testing and continued through out the study.

Potassium chloridedrug

Potassium Chloride 40-50meq was given daily for 5 weeks before baseline visit for testing and continued through out the study.