NCT05504083

Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients

A Multicenter Randomized and Controlled Phase IIb Study to Evaluate the Efficacy and Safety of D-0120 Tablets in Patients with Primary Hyperuricemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
DRUG	D-0120	Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.
DRUG	Benzbromarone	Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group.

Timeline

• Start date: 2022-09-28
• Primary completion: 2024-05-18
• Completion: 2024-05-18
• First posted: 2022-08-17
• Last updated: 2024-10-15

Locations

24 sites across 1 country: China

Regulatory

• FDA-regulated drug study