Gout and Hyperuricemia
Conditions
Brief summary
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.
Interventions
Sponsors
Ardea Biosciences, Inc.
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject meets any of the following criteria and with sUA ≤10.0 mg/dL: 1. sUA level of \>7.0 mg/dL at 7 days prior to baseline with gout; 2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome); 3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.
Exclusion criteria
* Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit. * Subject has a history or suspicion of kidney stones. * Subject has an estimated creatinine clearance \<60 mL/min calculated by the Cockcroft Gault formula * Subject is receiving strong or moderate CYP3A inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Changes of Serum Uric Acid Levels From Baseline Levels | Baseline and Week 16 | The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Weeks 1,2,4,6,8,10,12,16,18,20,24 | To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit |
| Percent Change in sUA | Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24 | To compare percent change in sUA at each study visit. |
| Absolute Change of Serum Uric Acid Levels From Baseline Levels | Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24 | To compare the absolute change of serum uric acid levels from baseline levels |
Countries
Japan
Participant flow
Recruitment details
Of the 381 subjects who were screened in the study, 204 were randomized into one of the treatment groups. All 204 randomized subjects received at least 1 dose of randomized study medication. The first patient was enrolled on 11 March 2014 and the last enrolled patient completed the Last visit on 13 March 2015.
Pre-assignment details
204 were randomized into one of the following treatment groups; allopurinol, placebo, RDEA3170 Group 1, Group 2 and Group 3. Of the enrolled subjects, 177 were withdrawn prior to randomization because of 'eligibility criteria not fulfill' (176 subjects) or 'patient decision' (1 subject).
Participants by arm
| Arm | Count |
|---|---|
| Allopurinol 200 mg Treatment Group 100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks | 41 |
| RDEA3170 Placebo Treatment Group RDEA3170 matching placebo qd for 24 weeks | 40 |
| RDEA3170 Treatment Group 1 RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks | 41 |
| RDEA3170 Treatment Group 2 RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks | 41 |
| RDEA3170 Treatment Group 3 RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks | 41 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 3 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 2 | 2 | 3 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Allopurinol 200 mg Treatment Group | RDEA3170 Placebo Treatment Group | RDEA3170 Treatment Group 1 | RDEA3170 Treatment Group 2 | RDEA3170 Treatment Group 3 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 51.0 Years STANDARD_DEVIATION 10.6 | 54.5 Years STANDARD_DEVIATION 10.3 | 51.3 Years STANDARD_DEVIATION 9.3 | 52.7 Years STANDARD_DEVIATION 10 | 52.3 Years STANDARD_DEVIATION 10.7 | 52.3 Years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 41 Participants | 39 Participants | 41 Participants | 40 Participants | 39 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 41 | 23 / 40 | 26 / 41 | 26 / 41 | 21 / 41 |
| serious Total, serious adverse events | 1 / 41 | 1 / 40 | 1 / 41 | 1 / 41 | 0 / 41 |
Outcome results
Primary
Percent Changes of Serum Uric Acid Levels From Baseline Levels
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
Time frame: Baseline and Week 16
Population: Efficacy analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RDEA3170 Treatment Group 1 | Percent Changes of Serum Uric Acid Levels From Baseline Levels | -30.93 Percent change | Standard Deviation 17.8 |
| RDEA3170 Treatment Group 2 | Percent Changes of Serum Uric Acid Levels From Baseline Levels | -49.91 Percent change | Standard Deviation 18.38 |
| RDEA3170 Treatment Group 3 | Percent Changes of Serum Uric Acid Levels From Baseline Levels | -54.32 Percent change | Standard Deviation 13.4 |
| RDEA3170 Placebo Treatment Group | Percent Changes of Serum Uric Acid Levels From Baseline Levels | -2.05 Percent change | Standard Deviation 9.29 |
| Allopurinol 200 mg Treatment Group | Percent Changes of Serum Uric Acid Levels From Baseline Levels | -39.09 Percent change | Standard Deviation 11.54 |
p-value: <0.000195% CI: [-36.99, -21.57]ANCOVA, LOCF
p-value: <0.000195% CI: [-56.97, -41.52]ANCOVA, LOCF
p-value: <0.000195% CI: [-61, -45.67]ANCOVA, LOCF
Secondary
Absolute Change of Serum Uric Acid Levels From Baseline Levels
To compare the absolute change of serum uric acid levels from baseline levels
Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Population: Efficacy analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 10 | -2.19 mg/dL | Standard Deviation 1.65 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 12 | -2.44 mg/dL | Standard Deviation 1.56 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 1 | -1.68 mg/dL | Standard Deviation 1.01 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 18 | -2.86 mg/dL | Standard Deviation 1.54 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 6 | -2.78 mg/dL | Standard Deviation 1.34 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 20 | -2.87 mg/dL | Standard Deviation 1.61 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 24 | -3.10 mg/dL | Standard Deviation 1.67 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 4 | -2.01 mg/dL | Standard Deviation 1.09 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 16 | -2.67 mg/dL | Standard Deviation 1.48 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 8 | -2.44 mg/dL | Standard Deviation 1.48 |
| RDEA3170 Treatment Group 1 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 2 | -1.81 mg/dL | Standard Deviation 1.11 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 8 | -2.61 mg/dL | Standard Deviation 1.75 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 12 | -3.85 mg/dL | Standard Deviation 1.62 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 10 | -3.22 mg/dL | Standard Deviation 1.78 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 2 | -1.75 mg/dL | Standard Deviation 1.45 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 1 | -1.74 mg/dL | Standard Deviation 1.48 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 20 | -3.98 mg/dL | Standard Deviation 1.97 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 4 | -1.72 mg/dL | Standard Deviation 1.48 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 24 | -3.99 mg/dL | Standard Deviation 1.96 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 18 | -4.17 mg/dL | Standard Deviation 1.82 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 6 | -2.66 mg/dL | Standard Deviation 1.73 |
| RDEA3170 Treatment Group 2 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 16 | -4.24 mg/dL | Standard Deviation 1.82 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 10 | -3.75 mg/dL | Standard Deviation 1.19 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 1 | -1.68 mg/dL | Standard Deviation 2.1 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 2 | -1.78 mg/dL | Standard Deviation 0.98 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 4 | -2.07 mg/dL | Standard Deviation 1.01 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 6 | -3.00 mg/dL | Standard Deviation 1.09 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 8 | -2.74 mg/dL | Standard Deviation 1.23 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 12 | -4.33 mg/dL | Standard Deviation 1.45 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 16 | -4.57 mg/dL | Standard Deviation 1.28 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 18 | -4.62 mg/dL | Standard Deviation 1.27 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 20 | -4.52 mg/dL | Standard Deviation 1.15 |
| RDEA3170 Treatment Group 3 | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 24 | -4.57 mg/dL | Standard Deviation 1.64 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 6 | -0.04 mg/dL | Standard Deviation 0.81 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 1 | -0.05 mg/dL | Standard Deviation 0.77 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 2 | -0.07 mg/dL | Standard Deviation 0.64 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 24 | -0.42 mg/dL | Standard Deviation 0.9 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 20 | -0.22 mg/dL | Standard Deviation 0.75 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 4 | 0.06 mg/dL | Standard Deviation 0.76 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 10 | -0.06 mg/dL | Standard Deviation 0.79 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 16 | -0.22 mg/dL | Standard Deviation 0.81 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 18 | -0.27 mg/dL | Standard Deviation 0.75 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 8 | 0.02 mg/dL | Standard Deviation 0.85 |
| RDEA3170 Placebo Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 12 | 0.02 mg/dL | Standard Deviation 0.7 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 1 | -1.82 mg/dL | Standard Deviation 0.73 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 12 | -3.35 mg/dL | Standard Deviation 1.09 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 6 | -3.26 mg/dL | Standard Deviation 0.93 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 16 | -3.44 mg/dL | Standard Deviation 1.1 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 4 | -1.83 mg/dL | Standard Deviation 0.89 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 24 | -3.31 mg/dL | Standard Deviation 1.1 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 18 | -3.40 mg/dL | Standard Deviation 1.06 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 2 | -1.83 mg/dL | Standard Deviation 0.9 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 20 | -3.35 mg/dL | Standard Deviation 1.15 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 10 | -2.96 mg/dL | Standard Deviation 1.13 |
| Allopurinol 200 mg Treatment Group | Absolute Change of Serum Uric Acid Levels From Baseline Levels | Week 8 | -3.22 mg/dL | Standard Deviation 1.09 |
Secondary
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
Time frame: Weeks 1,2,4,6,8,10,12,16,18,20,24
Population: Efficacy analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 2 | 29.3 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 1 | 26.8 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 12 | 53.7 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 18 | 63.4 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 6 | 70.7 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 10 | 46.3 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 20 | 61.0 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 4 | 26.8 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 16 | 51.2 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 8 | 53.7 % subjects |
| RDEA3170 Treatment Group 1 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 24 | 68.3 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 8 | 56.1 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 12 | 85.4 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 10 | 78.0 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 2 | 34.1 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 1 | 31.7 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 20 | 82.9 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 4 | 31.7 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 18 | 92.7 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 6 | 61.0 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 24 | 82.9 % subjects |
| RDEA3170 Treatment Group 2 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 16 | 95.1 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 10 | 92.7 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 1 | 39.0 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 2 | 34.1 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 4 | 39.0 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 6 | 82.9 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 8 | 78.0 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 12 | 92.7 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 16 | 97.6 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 18 | 95.1 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 20 | 92.7 % subjects |
| RDEA3170 Treatment Group 3 | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 24 | 87.8 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 6 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 1 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 2 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 24 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 20 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 4 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 10 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 16 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 18 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 8 | 0 % subjects |
| RDEA3170 Placebo Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 12 | 0 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 1 | 19.5 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 12 | 75.6 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 6 | 73.2 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 16 | 78.0 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 4 | 17.1 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 24 | 75.6 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 18 | 73.2 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 2 | 19.5 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 20 | 78.0 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 10 | 61.0 % subjects |
| Allopurinol 200 mg Treatment Group | Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | Week 8 | 65.9 % subjects |
Secondary
Percent Change in sUA
To compare percent change in sUA at each study visit.
Time frame: Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Population: Efficacy analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 1 | -19.72 % Change | Standard Deviation 10.93 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 16 | -30.93 % Change | Standard Deviation 17.8 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 4 | -22.95 % Change | Standard Deviation 10.86 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 12 | -28.08 % Change | Standard Deviation 18.22 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 6 | -32.05 % Change | Standard Deviation 13.05 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 10 | -24.69 % Change | Standard Deviation 18.81 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 24 | -35.73 % Change | Standard Deviation 19.49 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 18 | -32.94 % Change | Standard Deviation 18.11 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 2 | -21.03 % Change | Standard Deviation 11.87 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 20 | -32.96 % Change | Standard Deviation 18.69 |
| RDEA3170 Treatment Group 1 | Percent Change in sUA | Week 8 | -27.94 % Change | Standard Deviation 16.54 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 1 | -20.29 % Change | Standard Deviation 17.51 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 16 | -49.91 % Change | Standard Deviation 18.38 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 18 | -49.04 % Change | Standard Deviation 19.19 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 2 | -20.28 % Change | Standard Deviation 16.87 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 24 | -47.34 % Change | Standard Deviation 21.39 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 4 | -19.66 % Change | Standard Deviation 17.24 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 12 | -45.77 % Change | Standard Deviation 17.94 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 6 | -31.26 % Change | Standard Deviation 19.83 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 8 | -30.19 % Change | Standard Deviation 19.22 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 10 | -37.61 % Change | Standard Deviation 18.35 |
| RDEA3170 Treatment Group 2 | Percent Change in sUA | Week 20 | -47.20 % Change | Standard Deviation 21.46 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 10 | -44.38 % Change | Standard Deviation 12.33 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 2 | -20.93 % Change | Standard Deviation 10.68 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 24 | -54.46 % Change | Standard Deviation 18.97 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 8 | -32.11 % Change | Standard Deviation 13.96 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 16 | -54.32 % Change | Standard Deviation 13.4 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 20 | -53.60 % Change | Standard Deviation 12.92 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 18 | -54.70 % Change | Standard Deviation 13.32 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 4 | -24.21 % Change | Standard Deviation 10.69 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 12 | -51.17 % Change | Standard Deviation 16.19 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 6 | -35.24 % Change | Standard Deviation 10.74 |
| RDEA3170 Treatment Group 3 | Percent Change in sUA | Week 1 | -19.93 % Change | Standard Deviation 22.98 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 20 | -2.27 % Change | Standard Deviation 8.76 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 16 | -2.05 % Change | Standard Deviation 9.29 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 1 | -0.25 % Change | Standard Deviation 8.57 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 2 | -0.53 % Change | Standard Deviation 7.2 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 4 | 0.97 % Change | Standard Deviation 8.7 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 6 | -0.01 % Change | Standard Deviation 9.86 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 8 | 0.55 % Change | Standard Deviation 9.5 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 10 | -0.27 % Change | Standard Deviation 9.53 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 12 | 0.43 % Change | Standard Deviation 7.89 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 18 | -2.86 % Change | Standard Deviation 8.55 |
| RDEA3170 Placebo Treatment Group | Percent Change in sUA | Week 24 | -4.67 % Change | Standard Deviation 10.36 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 18 | -38.59 % Change | Standard Deviation 10.32 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 12 | -37.96 % Change | Standard Deviation 10.65 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 10 | -33.42 % Change | Standard Deviation 11.28 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 8 | -36.51 % Change | Standard Deviation 11.14 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 6 | -37.06 % Change | Standard Deviation 8.72 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 20 | -38.00 % Change | Standard Deviation 11.11 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 4 | -20.60 % Change | Standard Deviation 8.83 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 2 | -20.80 % Change | Standard Deviation 9.37 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 1 | -20.74 % Change | Standard Deviation 7.72 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 16 | -39.09 % Change | Standard Deviation 11.54 |
| Allopurinol 200 mg Treatment Group | Percent Change in sUA | Week 24 | -37.77 % Change | Standard Deviation 11.47 |