Status:
UNKNOWN
Clinical Trial for GNX80 in Intermittent Claudication
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Intermittent Claudication
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 d...
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 ...
Eligibility Criteria
Inclusion
- Age of at least 20 years
- Angiographically confirmed peripheral arterial disease
- Intermittent claudication for more than 6 months
Exclusion
- 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
Key Trial Info
Start Date :
September 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05400395
Start Date
September 5 2022
End Date
August 1 2024
Last Update
October 27 2022
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea