Trial · NCT02317861
A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients
NCT02317861, Phase 1, Phase 2, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients. Trials, record NCT02317861. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02317861
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients
- NCT number
- NCT02317861
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Gout and Asymptomatic Hyperuricemia
- Interventions
- RDEA3170, Febuxostat, Benzbromarone
- First posted
- 2014-12-17
- Last updated
- 2015-06-12
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum uric acid level | baseline and day 7 on each treatment | % change per treatment will be compared. |
| Primary | Change in Urinary excretion of uric acid | baseline and day 7 on each treatment | Timed urinary uric acid excretion per treatment will be compared |
| Primary | Renal clearance of uric acid | baseline and day 7 on each treatment | Renal clearance of uric acid will be calculated. |
| Primary | Fractional excretion of uric acid | baseline and day 7 on each treatment | Fractional excretion and renal clearance of uric acid will be calculated. |
| Secondary | Maximum plasma concentration (Cmax) | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. |
| Secondary | Time to reach maximum concentration (tmax) | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. |
| Secondary | Area under the concentration-time curve (AUC) | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. |
| Secondary | Half life (t1/2) | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. |
| Secondary | Incidence of adverse events | Day 1 and Day 7 on each treatment | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 |
| Secondary | Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters | Day 1 and Day 8 on each treatment | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02317861
GET https://conductscience.org/api/trials/v1/NCT02317861/registered