Trial record 1 of 8 for:
lesinurad
Lesinurad and Allopurinol Combination Extension Study in Gout
This study is enrolling participants by invitation only.
Sponsor:
Ardea Biosciences, Inc.
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01808131
First received: March 7, 2013
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
| Condition | Intervention | Phase |
|---|---|---|
|
Gout |
Drug: Lesinurad |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ardea Biosciences, Inc.:
Primary Outcome Measures:
- Proportion of subjects with an sUA level that is < 6.0 mg/dL [ Time Frame: Up to approximately 2.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Incidence of treatment emergent adverse events [ Time Frame: Up to approximately 2.5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 800 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: lesinurad 200 mg + allopurinol |
Drug: Lesinurad
Tablets, 200 mg QD
|
| Experimental: lesinurad 400 mg + allopurinol |
Drug: Lesinurad
Tablets, 400 mg QD
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808131
Locations
| United States, California | |
| Irvine, California, United States, 92618 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| Brooksville, Florida, United States, 34601 | |
| Pembroke Pines, Florida, United States, 33027 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Illinois | |
| Gurnee, Illinois, United States, 60031 | |
| United States, Kentucky | |
| Elizabethtown, Kentucky, United States, 42701 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44122 | |
| Dayton, Ohio, United States, 45417 | |
| Perrysburg, Ohio, United States, 43551 | |
| United States, Pennsylvania | |
| Clairton, Pennsylvania, United States, 15025 | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| United States, South Carolina | |
| Columbia, South Carolina, United States, 29204 | |
| United States, Tennessee | |
| Brentwood, Tennessee, United States, 37027 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M9W4L6 | |
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
| Study Director: | Chris Storgard, MD | Ardea Biosciences, Inc. |
More Information
No publications provided
| Responsible Party: | Ardea Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01808131 History of Changes |
| Other Study ID Numbers: | RDEA594-306, 2012-004389-16 |
| Study First Received: | March 7, 2013 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products New Zealand: Medsafe Canada: Health Canada |
Keywords provided by Ardea Biosciences, Inc.:
|
Gout |
Additional relevant MeSH terms:
|
Gout Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Allopurinol Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013