A Randomized Clinical Trial for GNX80 in Intermittent Claudication

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.

Criteria

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