Clinical Trial for GNX80 in Intermittent Claudication

Phase 4

Recruiting

• Conditions: Intermittent Claudication
• Interventions: Drug: GNX80; Drug: Placebo

• Registration Number: NCT05400395
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.

Detailed Description

A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-01
• Study Start: 2022-09-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27
• Primary Completion: 2024-03
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age of at least 20 years
• Angiographically confirmed peripheral arterial disease
• Intermittent claudication for more than 6 months

Exclusion Criteria

• Severe impairment of heart, liver, or kidney function
• Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition
• Poorly controlled diabetes mellitus
• Positive pregnancy test
• Planned surgical or endovascular procedures other than for the treatment of IC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GNX	GNX80	GNX / 80mg / BID / PO
Placebo	Placebo	Placebo / BID / PO

Primary Outcome Measures

Name	Time	Method
Walking Distance in comparison with the findings from at baseline	24 weeks	walking distance evaluated by a constant treadmill test

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of