Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603142
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Phase IIIII Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Parallel-Controlled Phase IIIII Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None