Lesinurad and Allopurinol Combination Extension Study in Gout

Gout Clinical Trial

Official title:

A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808131
• Other study ID #: RDEA594-306
• Secondary ID: 2012-004389-16
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2013
• Last updated: January 23, 2017
• Start date: February 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• 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 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.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Lesinurad
Tablets, 200 mg QD
• 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,  Poland,  South Africa,  Spain,  Switzerland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with an sUA level that is < 6.0 mg/dL		up to a total of 5 years
Secondary	Resolution of at least 1 target tophi		Up to Month 12