Clinical Trial for GNX80 in Intermittent Claudication

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

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.

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

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