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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01808131




Registration number
NCT01808131
Ethics application status
Date submitted
7/03/2013
Date registered
11/03/2013
Date last updated
24/01/2017

Titles & IDs
Public title
Lesinurad and Allopurinol Combination Extension Study in Gout
Scientific title
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
Secondary ID [1] 0 0
2012-004389-16
Secondary ID [2] 0 0
RDEA594-306
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

Experimental: lesinurad 200 mg + allopurinol -

Experimental: lesinurad 400 mg + allopurinol - Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015.


Treatment: Drugs: Lesinurad
Tablets, 200 mg QD

Treatment: Drugs: Lesinurad
Tablets, 400 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with an sUA level that is < 6.0 mg/dL
Timepoint [1] 0 0
up to a total of 5 years
Secondary outcome [1] 0 0
Resolution of at least 1 target tophi
Timepoint [1] 0 0
Up to 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 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
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
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
717
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Heidelberg West
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
- Woodville South
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 0 0
QLD 4152 - Brisbane
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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Colorado
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Florida
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Georgia
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United States of America
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Hawaii
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Idaho
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Genk
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Lommel
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Yvoir
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Birkinhead
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New Zealand
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Hamilton
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New Zealand
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Rotorua
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New Zealand
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Tauranga
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Malopolskie
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Slaskie
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Warszawa
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Durban
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Limpopo
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Pretoria
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Paarl
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Rondebosch
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Stellenbosch
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Witbank
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Worcester
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Vaud
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Kharkiv
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Kyiv
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Poltava
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Ukraine
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Vinnytsia

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 allopurinol over a long-term timeframe.
Trial website
https://clinicaltrials.gov/study/NCT01808131
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/NCT01808131