Lesinurad and Allopurinol Combination Extension Study in Gout

Ardea Biosciences

Status and phase

Completed

Phase 3

Conditions

Gout

Treatments

Drug: Lesinurad

Study type

Interventional

Funder types

Industry

Identifiers

NCT01808131

2012-004389-16 (EudraCT Number)

RDEA594-306

Details and patient eligibility

About

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

Full description

This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.

Enrollment

717 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.