Allopurinol Combination Study - RDEA594-203

Study identifier:RDEA594-203

ClinicalTrials.gov identifier:NCT01001338

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients with an Inadequate Hypouricemic Response with Standard Doses of Allopurinol

Medical condition

Gout

Phase

Phase 2

Healthy volunteers

No

Study drug

RDEA594, Placebo, Allopurinol

Sex

All

Actual Enrollment

227

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Jan 2011
Study Completion Date: 01 Aug 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Factorial Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2017 by Ardea Biosciences, Inc.

Sponsors

Ardea Biosciences, Inc.

Collaborators

-

Inclusion and exclusion criteria