Open-Label Lesinurad Monotherapy Extension Study in Gout

Gout Clinical Trial

Official title:

A Long-Term Open-Label Extension Study for Subjects Completing a Phase 3 Efficacy and Safety Study of Lesinurad Monotherapy in Subjects With Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650246
• Other study ID #: RDEA594-305
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2012
• Last updated: March 23, 2015
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesNew Zealand: MedsafeCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• lesinurad
Tablets, 400 mg QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with an sUA level that is < 6.0 mg/dL		Up to approximately 2 years	No
Primary	Incidence of TEAEs		Up to approximately 2 years	Yes