CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Verinurad +3 moredrug
Likely dose
Not stated in 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/NCT03316131
NCT03316131Phase 2Completed
CompareCT.gov

Quantifying Uric Acid Excretion With RDEA3170, Febuxostat and Dapagliflozin

AstraZeneca·interventional·Posted Oct 20, 2017·Updated Aug 28, 2019

In Brief

A Phase 2 clinical trial evaluating Verinurad, Febuxostat, and 2 other interventions for Asymptomatic Hyperuricemia. Completed, enrolled 36 participants across 2 sites.

Detailed Summary

This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsymptomatic Hyperuricemia
CountriesUnited States
CollaboratorsContract Research Organization: USA, PAREXEL Early Phase Clinical Unit Baltimore, PAREXEL Early Phase Clinical Unit-Los Angeles, Clinical Laboratory: USA, Harbor Hospital Laboratory, GenX Laboratories Inc., Analytical Laboratory (Pharmacokinetic Sample Analysis): USA, Covance Bioanalytical Services, LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 20, 2017
Enrollment StartOct 25, 2017
Primary CompletionJul 19, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.7 years ago

Interventions

Verinuraddrug

Randomized patients will receive orally once daily fixed dose of verinurad in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

Febuxostatdrug

Randomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

Dapagliflozindrug

Randomized patients will receive orally once daily fixed dose of dapagliflozin in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo

Dapagliflozin matched placeboother

Randomized patients will receive orally once daily fixed dose of dapagliflozin matched placebo in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo