Trial · NCT03316131
A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
NCT03316131, Phase 2, Completed, AstraZeneca; results first posted 2019-07-18
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA. Trials, record NCT03316131. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03316131
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
- NCT number
- NCT03316131
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asymptomatic Hyperuricemia
- Interventions
- Verinurad, Febuxostat, Dapagliflozin, Dapagliflozin matched placebo
- First posted
- 2017-10-20
- Last updated
- 2019-08-28
- Results first posted
- 2019-07-18
- Limitations and caveats
The initial plan was to recruit 24 patients, but due to difficulties in determining the peak urinary uric acid excretion in 11 patients, it was decided to include 12 additional patients to ensure adequate sample size.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 | On Day -1 and Day 7 of each treatment period | Change from baseline in peak UA excretion during the first 8 hours on Day 7 of treatment to assess the effects of intensive UA lowering therapy with verinurad, febuxostat and dapagliflozin. Urine sample was collected in hourly intervals, and the highest amount of UA excreted in any interval was designated as peak UA excretion for each patient and treatment period. |
| Primary | Change From Baseline in Plasma Concentration (Cmax) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | Cmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin |
| Primary | Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | AUClast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin |
| Primary | Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | AUCτ assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin |
| Secondary | Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7 | At Day -1 and Day 7 | Change from baseline in sUA to assess the intensive UA lowering effect of RDEA3170, febuxostat and dapagliflozin by evaluating the sUA levels after 7 days of treatment. |
| Secondary | Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | tmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin |
| Secondary | Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | tlast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 | On Day -1 and Day 7 of each treatment period | Protocol Analysis Set | milligrams (mg) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Plasma Concentration (Cmax) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | Pharmacokinetic Analysis Set | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | Pharmacokinetic Analysis Set | h∙ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7 | At Day -1 and Day 7 | Pharmacodynamic Analysis Set | umol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | Pharmacokinetic Analysis Set | hour | MEDIAN |
| SECONDARY | Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | Pharmacokinetic Analysis Set | hour | MEDIAN |
| PRIMARY | Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7 | On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose) | Pharmacokinetic Analysis Set | h∙ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 | Treatment Sequence A+B | -12.87 | 95% Confidence Interval -21.03 to -4.70 | milligrams (mg) | |
| Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 | Treatment Sequence B+A | -13.15 | 95% Confidence Interval -21.31 to -4.98 | milligrams (mg) | |
| Change From Baseline in Plasma Concentration (Cmax) on Day 7 | Treatment Sequence A+B | Verinurad | 17.52 | Geometric Coefficient of Variation 45.87 | ng/mL |
| Change From Baseline in Plasma Concentration (Cmax) on Day 7 | Treatment Sequence B+A | Verinurad | 15.26 | Geometric Coefficient of Variation 52.48 | ng/mL |
| Change From Baseline in Plasma Concentration (Cmax) on Day 7 | Treatment Sequence A+B | M1 | 25.28 | Geometric Coefficient of Variation 41.55 | ng/mL |
| Change From Baseline in Plasma Concentration (Cmax) on Day 7 | Treatment Sequence B+A | M1 | 25.61 | Geometric Coefficient of Variation 57.24 | ng/mL |
| Change From Baseline in Plasma Concentration (Cmax) on Day 7 | Treatment Sequence A+B | M8 | 18.45 | Geometric Coefficient of Variation 35.45 | ng/mL |
| Change From Baseline in Plasma Concentration (Cmax) on Day 7 | Treatment Sequence B+A | M8 | 18.42 | Geometric Coefficient of Variation 44.36 | ng/mL |
| Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7 | Treatment Sequence A+B | Verinurad | 149.1 | Geometric Coefficient of Variation 37.79 | h∙ng/mL |
| Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7 | Treatment Sequence B+A | Verinurad | 141.0 | Geometric Coefficient of Variation 44.90 | h∙ng/mL |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Treatment Sequence A+B | 18 | |
| Treatment Period 1 | STARTED | Treatment Sequence B+A | 18 | |
| Treatment Period 1 | COMPLETED | Treatment Sequence A+B | 18 | |
| Treatment Period 1 | COMPLETED | Treatment Sequence B+A | 18 | |
| Treatment Period 1 | NOT COMPLETED | Treatment Sequence A+B | 0 | |
| Treatment Period 1 | NOT COMPLETED | Treatment Sequence B+A | 0 | |
| Treatment Period 2 | STARTED | Treatment Sequence A+B | 18 | |
| Treatment Period 2 | STARTED | Treatment Sequence B+A | 18 | |
| Treatment Period 2 | COMPLETED | Treatment Sequence A+B | 17 | |
| Treatment Period 2 | COMPLETED | Treatment Sequence B+A | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Treatment Sequence A+B | 1 | 35 | |
| other | Diarrhoea | Gastrointestinal disorders | Treatment Sequence B+A | 1 | 36 | |
| other | Flatulence | Gastrointestinal disorders | Treatment Sequence A+B | 1 | 35 | |
| other | Flatulence | Gastrointestinal disorders | Treatment Sequence B+A | 1 | 36 | |
| other | Nausea | Gastrointestinal disorders | Treatment Sequence A+B | 0 | 35 | |
| other | Nausea | Gastrointestinal disorders | Treatment Sequence B+A | 1 | 36 | |
| other | Catheter Site Pain | General disorders | Treatment Sequence A+B | 0 | 35 | |
| other | Catheter Site Pain | General disorders | Treatment Sequence B+A | 1 | 36 | |
| other | Influenza Like Illness | General disorders | Treatment Sequence A+B | 1 | 35 | |
| other | Influenza Like Illness | General disorders | Treatment Sequence B+A | 0 | 36 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Sequence A+B | 0 | 35 |
| Total, all-cause mortality | Treatment Sequence B+A | 0 | 36 |
| Total, other adverse events | Treatment Sequence A+B | 7 | 35 |
| Total, other adverse events | Treatment Sequence B+A | 5 | 36 |
| Total, serious adverse events | Treatment Sequence A+B | 0 | 35 |
| Total, serious adverse events | Treatment Sequence B+A | 0 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33075806 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Sequence A+B vs Treatment Sequence B+A: deaths from any cause | Trial comparisons |
| Treatment Sequence A+B vs Treatment Sequence B+A: serious adverse events | Trial comparisons |
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/NCT03316131
GET https://conductscience.org/api/trials/v1/NCT03316131/results?page=2