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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004389-16 | EudraCT Number |
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This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lesinurad 200 mg + allopurinol | Experimental |
| |
| lesinurad 400 mg + allopurinol | Experimental | Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesinurad | Drug | Tablets, 200 mg QD |
| |
| Lesinurad |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with an sUA level that is < 6.0 mg/dL | up to a total of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of at least 1 target tophi | Up to Month 12 |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35213 | United States | |||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 21, 2017 | |
| Reset | Sep 19, 2017 |
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| Drug |
Tablets, 400 mg QD |
|
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Birmingham | Alabama | 35294 | United States |
| Gulf Shores | Alabama | 36542 | United States |
| Pinson | Alabama | 35126 | United States |
| Glendale | Arizona | 85308 | United States |
| Mesa | Arizona | 85203 | United States |
| Peoria | Arizona | 85381 | United States |
| Little Rock | Arkansas | 72206 | United States |
| Little Rock | Arkansas | 72211 | United States |
| Little Rock | Arkansas | 72223 | United States |
| Anaheim | California | 92805 | United States |
| Gold River | California | 95670 | United States |
| Irvine | California | 92618 | United States |
| Roseville | California | 95661 | United States |
| Sacramento | California | 95825 | United States |
| San Diego | California | 92108 | United States |
| San Leandro | California | 94578 | United States |
| San Ramon | California | 94582 | United States |
| Colorado Springs | Colorado | 80918 | United States |
| Colorado Springs | Colorado | 80922 | United States |
| Denver | Colorado | 80220 | United States |
| Englewood | Colorado | 80113 | United States |
| Brandon | Florida | 33511 | United States |
| Brooksville | Florida | 34601 | United States |
| Jacksonville | Florida | 32205 | United States |
| Jupiter | Florida | 33458 | United States |
| Miami | Florida | 33125 | United States |
| Miami | Florida | 33169 | United States |
| Miami | Florida | 33186 | United States |
| Ocala | Florida | 34474 | United States |
| Pembroke Pines | Florida | 33027 | United States |
| Plant City | Florida | 33563 | United States |
| Port Orange | Florida | 32127 | United States |
| Tampa | Florida | 33607 | United States |
| Tampa | Florida | 33634 | United States |
| Vero Beach | Florida | 32960 | United States |
| Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30328 | United States |
| Augusta | Georgia | 30909 | United States |
| Conyers | Georgia | 30013 | United States |
| Johns Creek | Georgia | 30097 | United States |
| Roswell | Georgia | 30075 | United States |
| Savannah | Georgia | 31406 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Meridian | Idaho | 83642 | United States |
| Meridian | Idaho | 83646 | United States |
| Gurnee | Illinois | 60031 | United States |
| Cedar Rapids | Iowa | 52403 | United States |
| Elizabethtown | Kentucky | 42701 | United States |
| Lexington | Kentucky | 40503 | United States |
| Paducah | Kentucky | 42003 | United States |
| Metairie | Louisiana | 70002 | United States |
| Metairie | Louisiana | 70006 | United States |
| Natchitoches | Louisiana | 71457 | United States |
| Cumberland | Maryland | 21502 | United States |
| Worcester | Massachusetts | 01605 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Flint | Michigan | 48504 | United States |
| Kalamazoo | Michigan | 49009 | United States |
| Southfield | Michigan | 48034 | United States |
| Traverse City | Michigan | 49684 | United States |
| Hazelwood | Missouri | 63042 | United States |
| Jefferson City | Missouri | 65109 | United States |
| Kansas City | Missouri | 64114 | United States |
| St Louis | Missouri | 63117 | United States |
| Washington | Missouri | 63090 | United States |
| Omaha | Nebraska | 68114 | United States |
| Reno | Nevada | 89502 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Brooklyn | New York | 11201 | United States |
| Hartsdale | New York | 10530 | United States |
| New York | New York | 10036 | United States |
| Calabash | North Carolina | 28467 | United States |
| Charlotte | North Carolina | 28210 | United States |
| Greensboro | North Carolina | 27405 | United States |
| Hickory | North Carolina | 28602 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Shelby | North Carolina | 28150 | United States |
| Shelby | North Carolina | 28152 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58103 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Cleveland | Ohio | 44122 | United States |
| Colombus | Ohio | 43235 | United States |
| Dayton | Ohio | 45417 | United States |
| Dayton | Ohio | 45424 | United States |
| Franklin | Ohio | 45005 | United States |
| Middleburg Heights | Ohio | 44130 | United States |
| Perrysburg | Ohio | 43551 | United States |
| Willoughby Hills | Ohio | 44094 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Portland | Oregon | 97220 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Clairton | Pennsylvania | 15025 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Indiana | Pennsylvania | 15701 | United States |
| Jenkintown | Pennsylvania | 19046 | United States |
| McMurray | Pennsylvania | 15317 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Scottdale | Pennsylvania | 15683 | United States |
| Columbia | South Carolina | 29204 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Myrtle Beach | South Carolina | 29588 | United States |
| Rock Hill | South Carolina | 29732 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Union | South Carolina | 29379 | United States |
| Knoxville | Tennessee | 37919 | United States |
| Knoxville | Tennessee | 37923 | United States |
| Memphis | Tennessee | 38119 | United States |
| Spring Hill | Tennessee | 37174 | United States |
| Austin | Texas | 78758 | United States |
| Dallas | Texas | 75218 | United States |
| Fort Worth | Texas | 76135 | United States |
| Houston | Texas | 77043 | United States |
| Houston | Texas | 77062 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77099 | United States |
| Irving | Texas | 75061 | United States |
| Kingwood | Texas | 77339 | United States |
| Nassau Bay | Texas | 77058 | United States |
| Plano | Texas | 75024 | United States |
| Plano | Texas | 75075 | United States |
| San Angelo | Texas | 76904 | United States |
| San Antonio | Texas | 78209 | United States |
| San Antonio | Texas | 78215 | United States |
| San Antonio | Texas | 78229 | United States |
| Sealy | Texas | 77474 | United States |
| Sugar Land | Texas | 77479 | United States |
| Waco | Texas | 76710 | United States |
| Bountiful | Utah | 84010 | United States |
| Layton | Utah | 84041 | United States |
| Salt Lake City | Utah | 84102 | United States |
| West Jordan | Utah | 84088 | United States |
| Danville | Virginia | 24541 | United States |
| Manassas | Virginia | 20110 | United States |
| Midlothian | Virginia | 23114 | United States |
| Richmond | Virginia | 23219 | United States |
| Richmond | Virginia | 23233 | United States |
| Richmond | Virginia | 23235 | United States |
| Virginia Beach | Virginia | 23462 | United States |
| Olympia | Washington | 98502 | United States |
| Seattle | Washington | 98104 | United States |
| Spokane | Washington | 99208 | United States |
| Tacoma | Washington | 98405 | United States |
| Morgantown | West Virginia | 26505 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Herston | Queensland | 4029 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Heidelberg West | Victoria | 3081 | Australia |
| Brisbane | QLD 4152 | Australia |
| Woodville South | 5011 | Australia |
| Genk | 3600 | Belgium |
| Kortrijk | 8500 | Belgium |
| Lommel | 3920 | Belgium |
| Yvoir | 5530 | Belgium |
| Coquitlam | British Columbia | V3K 3P4 | Canada |
| Penticton | British Columbia | V2A 5C8 | Canada |
| Kitchener | Ontario | N2M 5N6 | Canada |
| London | Ontario | N6A 5R8 | Canada |
| Toronto | Ontario | M9W4L6 | Canada |
| Québec | Quebec | G1V 3M7 | Canada |
| Eichstätt | Bavaria | 85072 | Germany |
| Goch | North Rhine-Westphalia | 47574 | Germany |
| Dresden | Saxony | 01069 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Kamenz | Saxony | 01917 | Germany |
| Leipzig | Saxony | 04109 | Germany |
| Grafton | Auckland | 1023 | New Zealand |
| Otahuhu | Auckland | 2025 | New Zealand |
| Beckenham | Christchurch | 8024 | New Zealand |
| Birkinhead | 0626 | New Zealand |
| Hamilton | 3204 | New Zealand |
| Rotorua | 3010 | New Zealand |
| Tauranga | 3143 | New Zealand |
| Poznan | Greater Poland Voivodeship | 60-773 | Poland |
| Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Katowice | Silesian Voivodeship | 40-954 | Poland |
| Warminsko-mazurskie | 82-300 | Poland |
| Warsaw | 01-192 | Poland |
| Gmina Końskie | Świętokrzyskie Voivodeship | 26-200 | Poland |
| Newlands | Durban | 4037 | South Africa |
| Silverglen | Durban | 4092 | South Africa |
| Newtown | Johannesburg | 2113 | South Africa |
| Parktown | Johannesburg | 2193 | South Africa |
| Radiokop | Johannesburg | 1724 | South Africa |
| Sowento | Johannesburg | 1804 | South Africa |
| Thabazimbi | Limpopo | 0380 | South Africa |
| Muckleneuk | Pretoria | 0002 | South Africa |
| Durban | 4001 | South Africa |
| Paarl | 7646 | South Africa |
| Rondebosch | 7700 | South Africa |
| Stellenbosch | 7600 | South Africa |
| Witbank | 1035 | South Africa |
| Worcester | 6850 | South Africa |
| Mérida | Badajoz | 06800 | Spain |
| A Coruña | 15006 | Spain |
| Lausanne | Canton of Vaud | CH-1011 | Switzerland |
| Kharkiv | 61157 | Ukraine |
| Kharkiv | 61176 | Ukraine |
| Kyiv | 01680 | Ukraine |
| Poltava | 36011 | Ukraine |
| Vinnytsia | 21018 | Ukraine |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 21, 2017 | Sep 19, 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 |
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