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To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDEA594 200 mg qd | Experimental | RDEA594 200 mg qd plus allopurinol qd |
|
| RDEA594 200 mg, 400 mg qd | Experimental | RDEA594 200 mg then 400 mg qd plus allopurinol qd. Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after protocol amendment 16 dated 07 October 2015. |
|
| Matching Placebo | Placebo Comparator | RDEA594 matching placebo qd plus allopurinol qd, then allopurinol qd alone in open label period. Patients on allopurinol qd alone were discontinued after protocol amendment 16 dated 07 October 2015. |
|
| RDEA594 600 mg qd | Experimental | RDEA594 200 mg then 400 mg then 600 mg plus allopurinol qd Patients on lesinurad 600 mg had their dose changed to lesinurad 200 mg after protocol amendment 16 dated 07 October 2015. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA594 | Drug | Uricosuric agent for the treatment of gout. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the percent reduction from baseline in serum urate levels following 4 wks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the proportion of subjects whose sUA levels are < 6.0 mg/dL, < 5.0 mg/dL and < 4.0 mg/dL at each study visit by treatment group in all subjects and in subjects who have an sUA ≥6 mg/dL at the baseline visit. | 28 days and through extension | |
| To evaluate the absolute and percent reduction from baseline in sUA levels at each visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nihar Bhakta, MD | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85050 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26742777 | Derived | Perez-Ruiz F, Sundy JS, Miner JN, Cravets M, Storgard C; RDEA594-203 Study Group. Lesinurad in combination with allopurinol: results of a phase 2, randomised, double-blind study in patients with gout with an inadequate response to allopurinol. Ann Rheum Dis. 2016 Jun;75(6):1074-80. doi: 10.1136/annrheumdis-2015-207919. Epub 2016 Jan 7. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 12, 2017 | |
| Unrelease | Yes | |
| Release | Aug 17, 2017 |
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| Placebo | Drug | Matching Placebo |
|
| Allopurinol | Drug | Allopurinol |
|
| 28 days and through extension |
| To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28. | 28 days and through extension |
| To evaluate the incidence of gout flares. | 28 days and through extension |
| To evaluate the safety and tolerability of RDEA594 in combination with allopurinol in subjects with gout. | 28 days and through extension |
| To compare the multiple-dose pharmacokinetics (PK) of allopurinol and oxypurinol in the absence versus presence of RDEA594 co-administration. | 28 days |
| To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL and <5.0 mg/dL in the Double-Blind and Open-Label Extension Period. | 3 years |
| La Jolla |
| California |
| 92037 |
| United States |
| Los Angeles | California | 90017 | United States |
| Stanford | California | 94305 | United States |
| Boca Raton | Florida | 33432 | United States |
| DeLand | Florida | 32720 | United States |
| Fort Lauderdale | Florida | 33334 | United States |
| Jupiter | Florida | 33458 | United States |
| Meridan | Idaho | 83642 | United States |
| Lexington | Kentucky | 40504 | United States |
| Wheaton | Maryland | 20902 | United States |
| Las Vegas | Nevada | 89183 | United States |
| Reno | Nevada | 89502 | United States |
| Harrisburg | North Carolina | 28075 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Cleveland | Ohio | 44122 | United States |
| Mayfield Village | Ohio | 44143 | United States |
| Durham | South Carolina | 27710 | United States |
| Rock Hill | South Carolina | 29732 | United States |
| Germantown | Tennessee | 38138 | United States |
| Jackson | Tennessee | 38305 | United States |
| Dallas | Texas | 75231 | United States |
| San Antonio | Texas | 78221 | United States |
| West Jordan | Utah | 84088 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Coquitlam | British Columbia | V3K 3P4 | Canada |
| Kelowna | British Columbia | V1Y8E7 | Canada |
| St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Thornhill | Ontario | L4J 6W6 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Mirabel | Quebec | J7J 2K8 | Canada |
| Bydgoszcz | 85-168 | Poland |
| Elblag | 82-300 | Poland |
| Lublin | 20-607 | Poland |
| Poznan | 60-773 | Poland |
| Radom | 26-610 | Poland |
| Torun | 87-100 | Poland |
| Bilbao | 48903 | Spain |
| Donetsk | 83045 | Ukraine |
| Kharkiv | 61176 | Ukraine |
| Kyiv | 01610 | Ukraine |
| Kyiv | 02125 | Ukraine |
| Vinnytsia | 21081 | Ukraine |
| Blackpool | Lancashire | FY4 3AD | United Kingdom |
| Reset | Sep 19, 2017 |
| Release | Nov 28, 2017 |
| Reset | Dec 21, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 12, 2017 | Yes | |||
| Aug 17, 2017 | Sep 19, 2017 | |||
| Nov 28, 2017 | Dec 21, 2017 |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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