Phase 3
Completed N=196
Lesinurad and Febuxostat Combination Extension Study in Gout
Source: ClinicalTrials.gov NCT01808144 ↗Enrolled (actual)
196
Serious AEs
17.9%
Results posted
Jan 2018
Primary outcomePrimary: Percentage of Participants With an sUA Level That is < 5.0 mg/dL — 82.5; 77.8 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an sUA Level That is < 5.0 mg/dL |
82.5; 77.8 | — |
| SECONDARY Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus |
61.0; 54.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
- Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
- Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.
Exclusion Criteria
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Data sourced from ClinicalTrials.gov (NCT01808144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.