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Open-Label Lesinurad Monotherapy Extension Study in Gout

Primary Purpose

Gout

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lesinurad
Sponsored by
Ardea Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lesinurad 400 mg

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Incidence of Treatment-emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Full Information

First Posted
July 24, 2012
Last Updated
April 20, 2016
Sponsor
Ardea Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01650246
Brief Title
Open-Label Lesinurad Monotherapy Extension Study in Gout
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardea Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lesinurad 400 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lesinurad
Intervention Description
Tablets, 400 mg QD
Primary Outcome Measure Information:
Title
Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL
Time Frame
Month 1
Title
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Storgard, MD
Organizational Affiliation
Ardea Biosciences, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
City
Trumbill
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
City
Meridian
State/Province
Indiana
ZIP/Postal Code
83646
Country
United States
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Landsdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29588
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
City
Spring Hill
State/Province
Tennessee
ZIP/Postal Code
37174
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
City
West Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
City
Suffold
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Genk
ZIP/Postal Code
3600
Country
Belgium
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 8W1
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
City
Dresden
ZIP/Postal Code
01069
Country
Germany
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
City
Silverglen
State/Province
Durban
ZIP/Postal Code
4092
Country
South Africa
City
Muckleneuk
State/Province
Pretoria
ZIP/Postal Code
0002
Country
South Africa
City
Rondebosch
ZIP/Postal Code
7700
Country
South Africa
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
City
Thabazimbi
ZIP/Postal Code
0380
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Open-Label Lesinurad Monotherapy Extension Study in Gout

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