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A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are: What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia? Researchers will compare AR882 Capsules with Febuxostat Tablets to see : Phase II: To explore the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia, aiming to determine the dosing regimen for the Phase III study Phase III: To evaluate the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia. Participants will: Be randomly assigned to receive either AR882 Capsules or Febuxostat Tablets. Undergo regular assessments of serum uric acid levels. Report any adverse events or side effects experienced during the study.
Details
| Lead sponsor | Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 636 |
| Start date | 2024-04-22 |
| Completion | 2026-04 |
Conditions
- Primary Gout
- Hyperuricemia
Interventions
- Febuxostat 20MG Tablets
- Febuxostat 20MG Placebo
- AR882 25MG
- AR882 12.5MG
- AR882 25MG Placebo
- AR882 12.5MG Placebo
- Febuxostat 40MG Tablets
- Febuxostat 40MG Placebo
Primary outcomes
- The percentage of participants with serum uric acid <360 μmol/L — 8 Weeks
Countries
China