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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004390-54 | EudraCT Number |
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This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat 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 febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lesinurad 400 mg + febuxostat 80 mg | Experimental | Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015. |
|
| lesinurad 200 mg + febuxostat 80 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lesinurad | Drug | Tablets, 400 mg once daily (QD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an sUA Level That is < 5.0 mg/dL | Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases | Up to approximately 2.5 years (at Extension Month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus | Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases) | Up to approximatley 2.5 years (at Extension 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 | 35211 | United States | |||
Subjects randomized to lesinurad (RDEA594) 200 mg or 400 mg + febuxostat (FBX) 80 mg in Study RDEA594-304 continued to receive the same dose in this study. Subjects randomized to placebo + febuxostat 80 mg in Study RDEA594-304 were randomized in a double-blind, 1:1 fashion to either lesinurad 200 mg or 400 mg + febuxostat 80 mg.
Subjects entered this extension Study RDEA594-307 while the core Study RDEA594-304 was ongoing and the database was not yet locked. To maintain the blind of the core study for subjects entering the extension, the lesinurad dose for all subjects in this extension study was blinded to the Sponsor until database lock of Study RDEA594-304.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lesinurad 200 mg + Febuxostat 80 mg | |
| FG001 | Lesinurad 400 mg + Febuxostat 80 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| lesinurad |
| Drug |
Tablets, 200 mg QD |
|
| febuxostat | Drug | Tabletsm 80 mg QD |
|
| Tempe |
| Arizona |
| 85282 |
| United States |
| Glendale | California | 91204 | United States |
| Huntington Beach | California | 92646 | United States |
| Irvine | California | 92618 | United States |
| San Diego | California | 92108 | United States |
| Denver | Colorado | 80220 | United States |
| Englewood | Colorado | 80113 | United States |
| Boynton Beach | Florida | 33472 | United States |
| Naples | Florida | 34102 | United States |
| Pembroke Pines | Florida | 33027 | United States |
| Tampa | Florida | 33606 | United States |
| Tampa | Florida | 33614 | United States |
| Winter Haven | Florida | 33880 | United States |
| Johns Creek | Georgia | 30097 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Meridian | Idaho | 83646 | United States |
| Gurnee | Illinois | 60031 | United States |
| Springfield | Illinois | 62704 | United States |
| Elizabethtown | Kentucky | 42701 | United States |
| Frederick | Maryland | 21702 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Southfield | Michigan | 48034 | United States |
| Jackson | Mississippi | 39202 | United States |
| Olive Branch | Mississippi | 38654 | United States |
| Jefferson City | Missouri | 65109 | United States |
| St Louis | Missouri | 63117 | United States |
| New York | New York | 10036 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Fargo | North Dakota | 58103 | United States |
| Columbus | Ohio | 43203 | United States |
| Middleburg Heights | Ohio | 44130 | United States |
| Wadsworth | Ohio | 44281 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Belle Vernon | Pennsylvania | 15012 | United States |
| Lansdale | Pennsylvania | 19446 | United States |
| Pittsburgh | Pennsylvania | 15206 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Columbia | South Carolina | 29204 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Memphis | Tennessee | 38119 | United States |
| Austin | Texas | 78705 | United States |
| Austin | Texas | 78758 | United States |
| Dallas | Texas | 75218 | United States |
| Houston | Texas | 77074 | United States |
| San Antonio | Texas | 78229 | United States |
| Sugar Land | Texas | 77479 | United States |
| Victoria | Texas | 77901 | United States |
| Waco | Texas | 76710 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Danville | Virginia | 24541 | United States |
| Richmond | Virginia | 23235 | United States |
| Seattle | Washington | 98104 | United States |
| Morgantown | West Virginia | 26505 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| Woodville South | South Australia | 5011 | Australia |
| Hobart | Tasmania | 7000 | Australia |
| Mississauga | Ontario | L5M 2V8 | Canada |
| Toronto | Ontario | M9W4L6 | Canada |
| Grafton | Auckland | 1023 | New Zealand |
| Tauranga | 3143 | New Zealand |
| Poznan | Greater Poland Voivodeship | 60-773 | Poland |
| Kutno | Iodzkie | 99-300 | Poland |
| Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| Bialystok | Podlaskie Voivodeship | 15-430 | Poland |
| Katowice | Silesian Voivodeship | 40-954 | Poland |
| Elblag | Warmian-Masurian Voivodeship | 82-300 | Poland |
| Gmina Końskie | Świętokrzyskie Voivodeship | 26-200 | Poland |
| Fribourg | 1705 | Switzerland |
| Fribourg | 1708 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lesinurad 400 mg + Febuxostat 80 mg | |
| BG001 | Lesinurad 200 mg + Febuxostat 80 mg | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Number | Participant |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an sUA Level That is < 5.0 mg/dL | Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases | Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed Extension Month 12. | Posted | Number | Percentage of participants | Up to approximately 2.5 years (at Extension Month 12) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus | Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases) | ITT Population Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed through Month 12. | Posted | Number | Percentage of participants | Up to approximatley 2.5 years (at Extension Month 12) |
|
|
Up to approximately 2.5 years (at Extension Month 12)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lesinurad 200 mg + Febuxostat 80 mg | 1 | 97 | 16 | 97 | 61 | 97 | |
| EG001 | Lesinurad 400 mg + Febuxostat 80 mg | 0 | 99 | 19 | 99 | 70 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Stag horn calculus | Renal and urinary disorders | MedDRA version 14.0. | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatinine increased | Investigations | MedDRA version 14.0. | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA version 14.0. | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 14.0. | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA version 14.0. | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 14.0. | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version 14.0. | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA version 14.0. | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0. | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 14.0. | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 14.0. | Systematic Assessment |
|
PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nihar Bhakta, MD | Ardea Biosciences, Inc. | 1-858-652-6671 | nbhakta@ardeabio.com |
| 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 |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Female |
|
| Canada |
|
| Poland |
|
| Switzerland |
|
| Australia |
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| New Zealand |
|
|