A Phase 2 interventional study of Verinurad and Febuxostat in Asymptomatic Hyperuricemia, sponsored by AstraZeneca. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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Among 27 studies in Gout by AstraZeneca — none open to participants now, none under way, none of them phase 3. Gout · AstraZeneca.
Among the 27 studies in Gout by AstraZeneca, this one is the 18th largest by enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2017, is one of 6 in phase 2, and was the 26th registered.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
Browse Gout studies →None of the 27 studies in Gout by AstraZeneca is open now. The open studies under Gout, anywhere →
Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 7 · Phase 3 7 · Phase 4 1
First in 2008; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 83 across 286 interventional studies indexed under Gout.
Median enrollment 87 across the 24 interventional studies, 223 across the 3 observational. Of the 26 that completed or were terminated, 14 (54%) have results posted.
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AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Gout by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit
This is a randomized, placebo controlled, double-blind, 2-way crossover study to assess the effect of intensive UA lowering therapy with verinurad (RDEA3170), febuxostat, and dapagliflozin on urinary excretion of UA, in asymptomatic hyperuricemic patients. Thirty-six asymptomatic hyperuricemic patients aged 18 to 65 years (inclusive) will be enrolled into this study at 2 study centers. Twenty-four patients have been enrolled and completed the study to date. Due to inadequate urine sampling, 12 additional patients were included to ensure an adequate sample size (at least 20 evaluable patients) to evaluate the effects of intensive UA lowering with verinurad, febuxostat and dapagliflozin on urinary excretion of UA. With 24 completers available during the interim analysis, this will provide for a total sample size of 36 evaluable patients.
Before any study specific assessments are performed, potential patients must provide informed consent. Each patient will undergo the below mentioned visits:
On Day -2 of Treatment period 1, patient will be randomized (1:1) to 1 of 2 treatment sequences (AB or BA). Each randomized patient will receive orally once daily fixed dose of the below mentioned 2 treatments for 7 consecutive days (1 treatment per treatment period).
Treatment Period 1 and Treatment Period 2 will be separated by a washout period of 7 to 21 days.
Patients will return to the Clinical Unit for a Follow-up Visit, 14 to 28 days after Day 1 of Treatment Period 2.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Randomized patients will receive orally once daily fixed dose of the following drugs: verinurad + febuxostat + dapagliflozin;
Drug: Verinurad · Drug: Febuxostat · Drug: Dapagliflozin
Randomized patients will receive orally once daily fixed dose of the following drugs: verinurad + febuxostat + dapagliflozin matched placebo
Drug: Verinurad · Drug: Febuxostat · Other: Dapagliflozin matched placebo
Randomized patients will receive orally once daily fixed dose of verinurad in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
Also known as: RDEA3170
Randomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
Also known as: ULORIC
Randomized patients will receive orally once daily fixed dose of dapagliflozin in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
Also known as: FARXIGA
Randomized patients will receive orally once daily fixed dose of dapagliflozin matched placebo in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7
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.
Time frame: On Day -1 and Day 7 of each treatment period
Change From Baseline in Plasma Concentration (Cmax) on Day 7
Cmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Time frame: 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)
Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7
AUClast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Time frame: 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)
Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7
AUCτ assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Time frame: 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)
Change From Baseline in Urinary Excretion of Serum UA (sUA) on 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.
Time frame: At Day -1 and Day 7
Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7
tmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Time frame: 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)
Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7
tlast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
Time frame: 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)
The trial was conducted at two study centres: Baltimore and Los Angeles. The date of the first subject visit was 25 Oct 2017 and the date of the last subject last visit was 19 Jul 2018. A total of 36 adults asymptomatic hyperuricemic patients were included into this study.
| Milestone | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Started | 18 | 18 |
| Completed | 17 | 18 |
| Not completed | 1 | 0 |
| Withdrew: Protocol deviation | 1 | 0 |
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.
| milligrams (mg) | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 | -12.87 (-21.03 to -4.70) | -13.15 (-21.31 to -4.98) |
Cmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
| ng/mL | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Verinurad | 17.52 ± 45.87 | 15.26 ± 52.48 |
| M1 | 25.28 ± 41.55 | 25.61 ± 57.24 |
| M8 | 18.45 ± 35.45 | 18.42 ± 44.36 |
AUClast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
| h∙ng/mL | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Verinurad | 149.1 ± 37.79 | 141.0 ± 44.90 |
| M1 | 212.7 ± 42.74 | 221.3 ± 49.13 |
| M8 | 174.2 ± 34.57 | 176.5 ± 36.85 |
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.
| umol/L | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7 | -327.161 (-352.559 to -301.762) | -264.851 (-290.060 to -239.643) |
tmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
| hour | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Verinurad | 4.00 (2.00 to 8.00) | 4.00 (3.00 to 8.08) |
| M1 | 4.00 (2.00 to 8.00) | 4.00 (3.00 to 4.03) |
| M8 | 4.00 (3.00 to 8.02) | 4.00 (3.00 to 8.08) |
tlast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
| hour | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Verinurad | 24.00 (23.85 to 24.47) | 24.00 (23.22 to 24.40) |
| M1 | 24.00 (23.85 to 24.47) | 24.00 (23.22 to 24.40) |
| M8 | 24.00 (23.85 to 24.47) | 24.00 (23.22 to 24.40) |
AUCτ assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin
| h∙ng/mL | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| Verinurad | 149.0 ± 37.84 | 140.9 ± 44.90 |
| M1 | 212.6 ± 42.78 | 221.1 ± 49.13 |
| M8 | 174.1 ± 34.59 | 176.3 ± 36.81 |
Collected over Adverse events were collected from the start of randomization throughout the treatment period up to and including the Follow-up Visit. Serious adverse events were recorded from the time of informed consent.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Sequence A+B | 0/35 (0%) | 0/35 (0%) | 7/35 (20%) |
| Treatment Sequence B+A | 0/36 (0%) | 0/36 (0%) | 5/36 (13.9%) |
| Event | Treatment Sequence A+B | Treatment Sequence B+A |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/35 | 1/36 |
| FlatulenceGastrointestinal disorders | 1/35 | 1/36 |
| Influenza Like IllnessGeneral disorders | 1/35 | 0/36 |
| Vessel Puncture Site HaematomaGeneral disorders | 1/35 | 1/36 |
| Eyelid InjuryInjury, poisoning and procedural complications | 1/35 | 0/36 |
| HeadacheNervous system disorders | 1/35 | 1/36 |
| InsomniaPsychiatric disorders | 1/35 | 0/36 |
| NauseaGastrointestinal disorders | 0/35 | 1/36 |
| Catheter Site PainGeneral disorders | 0/35 | 1/36 |
| Upper Respiratory Tract InfectionInfections and infestations | 0/35 | 1/36 |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 42.3 ± 12.01 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 1 |
| Male | 35 |
| Race (NIH/OMB)(Participants) | All Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 17 |
| White | 14 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2018, 8 months.
Results were first posted in Jul 2019, 11 months after primary completion.
Of 25 industry-sponsored phase 2 interventional studies under Gout, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 19. This study's 8 months is below that.
Counting every sponsor, half of 30 studies reached it within 14 months; a quarter within 7 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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