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

NCT06603142 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Primary Gout
  • Hyperuricemia

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

Sponsors & Collaborators

  • Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06603142 on ClinicalTrials.gov