Allopurinol Outcome Study
NCT01391325 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1735
Last updated 2014-06-17
Summary
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.
Conditions
Interventions
- DRUG
-
Allopurinol
Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
Sponsors & Collaborators
-
Ardea Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
S Baumgartner, MD · Ardea Biosciences, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2013-01-31
- Completion
- 2013-03-31
Countries
- United States
- Australia
- Belgium
- Canada
- Germany
- New Zealand
- South Africa
Study Locations
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