Lesinurad and Febuxostat Combination Extension Study in Gout

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808144
• Other study ID #: RDEA594-307
• Secondary ID: 2012-004390-54
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2013
• Last updated: January 3, 2018
• Start date: March 1, 2013
• Est. completion date: October 6, 2016

Study information

• Verified date: January 2018
• 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 febuxostat 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 febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: October 6, 2016
• Est. primary completion date: August 9, 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 Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg 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 control during the study and for at least 14 days after the last dose of study medication.

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, 400 mg once daily (QD)
• lesinurad
Tablets, 200 mg QD
• febuxostat
Tabletsm 80 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,  Canada,  New Zealand,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an sUA Level That is < 5.0 mg/dL	Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases	Up to approximately 2.5 years (at Extension Month 12)
Secondary	Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus	Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)	Up to approximatley 2.5 years (at Extension Month 12)