ARDEA BIOSCIENCES, INC./DE Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2017-08-14: Study NCT03272425; Company role Lead sponsor; Phase Phase 1; Status Completed.
- 2016-08-30: Study NCT02888054; Company role Lead sponsor; Phase Phase 1; Status Completed.
- 2015-11: Study NCT02608710; Company role Lead sponsor; Phase Phase 1; Status Completed.
- 2015-10: Study NCT02581553; Company role Lead sponsor; Phase Phase 1; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2017-08-14 | NCT03272425 Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence. | Lead sponsor | Phase 1 | Completed | Gout | 32 | 2017-10-04 |
| 2016-08-30 | NCT02888054 Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence | Lead sponsor | Phase 1 | Completed | Healthy | 28 | 2017-02-01 |
| 2015-11 | NCT02608710 RDEA3170 PK/PD Study | Lead sponsor | Phase 1 | Completed | Gout | 40 | 2016-04 |
| 2015-10 | NCT02581553 Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability | Lead sponsor | Phase 1 | Completed | Healthy | 116 | 2016-08 |
| 2015-07-28 | NCT02498652 Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects | Lead sponsor | Phase 2 | Completed Results posted | Gout | 41 | 2016-06-02 |
| 2015-05-01 | NCT02448368 RDEA3170 Tablet and Capsule Bioavailability Study | Lead sponsor | Phase 1 | Completed Results posted | Healthy | 35 | 2016-01-29 |
| 2015-04 | NCT02398448 IVIVR Assessing PK Parameters Used to Establish Bioequivalence | Lead sponsor | Phase 1 | Completed | Healthy | 20 | 2015-09 |
| 2015-04 | NCT02393560 DECT Study in Allopurinol-Treated Gout Patients | Lead sponsor | Observational | Completed | Gout | 223 | 2016-10 |
| 2014-12 | NCT02317861 A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients | Collaborator Lead: AstraZeneca | Phase 1, Phase 2 | Completed | Gout and Asymptomatic Hyperuricemia | 110 | 2015-06 |
| 2014-11-01 | NCT02279641 RDEA3170 and Allopurinol Combination Study in Gout Subjects | Lead sponsor | Phase 1 | Completed Results posted | Gout | 12 | 2015-09-11 |
| 2014-11 | NCT02336594 RDEA3170 Bioavailability Study | Lead sponsor | Phase 1 | Completed Results posted | Gout | 15 | 2015-03 |
| 2014-10 | NCT02246673 RDEA3170 and Febuxostat Combination Study in Gout Subjects | Lead sponsor | Phase 2 | Completed Results posted | Gout | 64 | 2016-02 |
| 2014-08-01 | NCT02219516 Mild, Moderate and Severe Renal Impairment Study | Lead sponsor | Phase 1 | Completed Results posted | Gout | 31 | 2016-05-13 |
| 2014-04 | NCT02127775 Lesinurad Tablet Bioequivalence | Lead sponsor | Phase 1 | Completed | Healthy | 54 | 2014-07 |
| 2014-01-05 | NCT02078219 Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia | Collaborator Lead: AstraZeneca | Phase 2 | Completed Results posted | Gout and Hyperuricemia | 204 | 2015-03-13 |
| 2014-01 | NCT02039700 Bioavailability of Lesinurad and Intravenous [14C]Lesinurad | Lead sponsor | Phase 1 | Completed | Healthy | 10 | 2014-04 |
| 2013-11 | NCT01986556 Lesinurad Tablet Relative Bioavailability | Lead sponsor | Phase 1 | Completed | Healthy | 36 | 2014-05 |
| 2013-11 | NCT01982201 Antacid Interaction Study | Lead sponsor | Phase 1 | Completed | Healthy | 24 | 2014-03 |
| 2013-10 | NCT02028689 Metformin and Furosemide Drug-Drug Interaction Study | Lead sponsor | Phase 1 | Completed | Healthy | 23 | 2014-01 |
| 2013-08 | NCT01927198 RDEA3170 Monotherapy in Subjects With Gout | Lead sponsor | Phase 2 | Completed | Gout | 172 | 2014-07 |
| 2013-08 | NCT01910506 RDEA3170 AME Study | Lead sponsor | Phase 1 | Completed | Healthy | 8 | 2013-11 |
| 2013-07 | NCT01908257 Lesinurad Interaction Study With Ranitidine | Lead sponsor | Phase 1 | Completed | Healthy | 16 | 2013-11 |
| 2013-06 | NCT01884272 NSAID Drug Interaction Study | Lead sponsor | Phase 1 | Completed | Gout | 24 | 2013-10 |
| 2013-06 | NCT01883167 RDEA3170 and Febuxostat Drug Interaction Study | Lead sponsor | Phase 1 | Completed | Healthy | 21 | 2013-12 |
| 2013-06 | NCT01872832 Single and Multiple Dose Study in Japanese Subjects | Lead sponsor | Phase 1 | Completed | Gout | 46 | 2013-11 |
| 2013-03-01 | NCT01808144 Lesinurad and Febuxostat Combination Extension Study in Gout | Lead sponsor | Phase 3 | Completed Results posted | Gout | 196 | 2016-10-06 |
| 2013-02 | NCT01808131 Lesinurad and Allopurinol Combination Extension Study in Gout | Lead sponsor | Phase 3 | Completed | Gout | 717 | 2016-11 |
| 2012-12 | NCT01744379 Single and Multiple Dose Study in Japanese | Lead sponsor | Phase 1 | Completed | Gout | 40 | 2013-05 |
| 2012-08 | NCT01650246 Open-Label Lesinurad Monotherapy Extension Study in Gout | Lead sponsor | Phase 3 | Completed Results posted | Gout | 143 | 2014-08 |
| 2012-01 | NCT01510769 Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat | Lead sponsor | Phase 3 | Completed Results posted | Tophaceous Gout | 330 | 2014-06 |
| 2012-01 | NCT01510158 Combining Lesinurad With Allopurinol in Inadequate Responders | Lead sponsor | Phase 3 | Completed Results posted | Gout | 607 | 2014-08 |
| 2012-01 | NCT01508702 Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors | Lead sponsor | Phase 3 | Completed Results posted | Gout | 214 | 2013-11 |
| 2011-12 | NCT01493531 Combining Lesinurad With Allopurinol in Inadequate Responders | Lead sponsor | Phase 3 | Completed Results posted | Gout | 610 | 2014-07 |
| 2011-07 | NCT01391325 Allopurinol Outcome Study | Lead sponsor | Phase 4 | Completed Results posted | Gout | 1,735 | 2013-03 |
| 2009-10 | NCT01001338 Allopurinol Combination Study | Lead sponsor | Phase 2 | Completed | Gout | 227 | 2016-08 |
| 2009-07 | NCT00955981 Gout Dose Response Study | Lead sponsor | Phase 2 | Completed | Hyperuricemia | 123 | 2011-09 |
| 2008-07 | NCT00741442 A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout | Lead sponsor | Phase 2 | Completed | Hyperuricemia | 3 | 2009-09 |
| 2008-01 | NCT00617526 Naïve HIV POC Monotherapy Trial | Lead sponsor | Phase 2 | Completed | HIV Infections | 48 | 2008-08 |