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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01808144




Registration number
NCT01808144
Ethics application status
Date submitted
7/03/2013
Date registered
11/03/2013
Date last updated
30/01/2018

Titles & IDs
Public title
Lesinurad and Febuxostat Combination Extension Study in Gout
Scientific 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
Secondary ID [1] 0 0
2012-004390-54
Secondary ID [2] 0 0
RDEA594-307
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lesinurad
Treatment: Drugs - lesinurad
Treatment: Drugs - febuxostat

Experimental: lesinurad 400 mg + febuxostat 80 mg - Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.

Experimental: lesinurad 200 mg + febuxostat 80 mg -


Treatment: Drugs: lesinurad
Tablets, 400 mg once daily (QD)

Treatment: Drugs: lesinurad
Tablets, 200 mg QD

Treatment: Drugs: febuxostat
Tabletsm 80 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Timepoint [1] 0 0
Up to approximately 2.5 years (at Extension Month 12)
Secondary outcome [1] 0 0
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Timepoint [1] 0 0
Up to approximatley 2.5 years (at Extension Month 12)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/10/2016
Sample size
Target
Accrual to date
Final
196
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Woodville South
Recruitment hospital [3] 0 0
- Hobart
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
West Virginia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
New Zealand
State/province [28] 0 0
Auckland
Country [29] 0 0
New Zealand
State/province [29] 0 0
Tauranga
Country [30] 0 0
Poland
State/province [30] 0 0
Iodzkie
Country [31] 0 0
Poland
State/province [31] 0 0
Malopolskie
Country [32] 0 0
Poland
State/province [32] 0 0
Podlaskie
Country [33] 0 0
Poland
State/province [33] 0 0
Slaskie
Country [34] 0 0
Poland
State/province [34] 0 0
Swietokrzyskie
Country [35] 0 0
Poland
State/province [35] 0 0
Warminsko-Mazurskie
Country [36] 0 0
Poland
State/province [36] 0 0
Wielkopolskie
Country [37] 0 0
Switzerland
State/province [37] 0 0
Fribourg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
Trial website
https://clinicaltrials.gov/study/NCT01808144
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nihar Bhakta, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01808144