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ACTIVE NOT RECRUITING
NCT06603142
PHASE2/PHASE3

Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia

Sponsor: Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

636

Start Date

2024-04-22

Completion Date

2026-04

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

Febuxostat 20MG Tablets

Febuxostat 20MG Tablets

DRUG

Febuxostat 20MG Placebo

Febuxostat 20MG Placebo

DRUG

AR882 25MG

AR882 25 MG Capsules

DRUG

AR882 12.5MG

AR882 12.5 MG Capsules

DRUG

AR882 25MG Placebo

AR882 25MG Placebo

DRUG

AR882 12.5MG Placebo

AR882 12.5MG Placebo

DRUG

Febuxostat 40MG Tablets

Febuxostat 40MG Tablets

DRUG

Febuxostat 40MG Placebo

Febuxostat 40MG Placebo

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Beijing, China