Lesinurad and Allopurinol Combination Extension Study in Gout

Completed · Phase 3

Conditions studied: Gout

In brief

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.

Key facts

Study ID

NCT01808131

Run by

Ardea Biosciences, Inc.

People needed

717

Starts

2013-02-01

Expected to finish

2016-11-01

Last updated by the study team

2017-01-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
• Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
• Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth

You may not qualify if…

• Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Gulf Shores, Alabama, United States
• Study site — Pinson, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Gold River, California, United States
• Study site — Irvine, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Leandro, California, United States
• Study site — San Ramon, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Brandon, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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