Open-Label Lesinurad Monotherapy 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 over a long-term timeframe.

Key facts

Study ID

NCT01650246

Run by

Ardea Biosciences, Inc.

People needed

143

Starts

2012-08-01

Expected to finish

2014-08-01

Last updated by the study team

2016-05-26

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 RDEA594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at Month 6 visit.
• Subject is willing to adhere to the visit/protocol schedules.
• 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 other 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.
• Subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis.
• Subject developed kidney stones during Study RDEA594-303

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Carmichael, California, United States
• Study site — Covina, California, United States
• Study site — Huntington Park, California, United States
• Study site — Irvine, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Trumbill, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plant City, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Newnan, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Meridian, Indiana, United States
• Study site — Elizabethtown, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.