Open-Label Lesinurad Monotherapy Extension Study in Gout

Ardea Biosciences

Status and phase

Completed

Phase 3

Conditions

Gout

Treatments

Drug: lesinurad

Study type

Interventional

Funder types

Industry

Identifiers

NCT01650246

RDEA594-305

Details and patient eligibility

About

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

Full description

This is a Phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in Study RDEA594-303.

Enrollment

143 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 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.

Exclusion criteria

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