CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 99 enrolled
Drug / intervention
Allopurinol +1 moredrug
Likely dose
Allopurinol 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02038179
NCT02038179Phase 3Completed

University of Alabama at Birmingham CORT Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

University of Alabama at Birmingham·interventional·Posted Jan 16, 2014·Updated Jan 11, 2021

In Brief

A Phase 3 clinical trial evaluating Allopurinol and Placebo for Pre-hypertension and JNC 7 Stage I Hypertension. Completed, enrolled 99 participants across 1 site.

Detailed Summary

We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole.

Study Details

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 16, 2014
Enrollment StartJul 1, 2014
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.5 years ago

Interventions

Allopurinoldrug

Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.

Placebodrug

Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.