Lesinurad and Febuxostat 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 febuxostat over a long-term timeframe.

Key facts

Study ID

NCT01808144

Run by

Ardea Biosciences, Inc.

People needed

196

Starts

2013-03-01

Expected to finish

2016-10-06

Last updated by the study team

2018-01-30

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 Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg 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 control during the study and for at least 14 days after the last dose of study medication.

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 — Tempe, Arizona, United States
• Study site — Glendale, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Irvine, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Johns Creek, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Meridian, Idaho, United States
• Study site — Gurnee, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Elizabethtown, Kentucky, United States
• Study site — Frederick, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Jackson, Mississippi, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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