Overview
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.
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
Eligibility
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