Intermittent Claudication
Conditions
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
Interventions
DRUGGNX80
GNX80 oral intake(BID) for 24 weeks
DRUGPlacebo
Placebo oral intake(BID) for 24 weeks
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Distance in comparison with the findings from at baseline | 24 weeks | walking distance evaluated by a constant treadmill test |
Countries
South Korea
Contacts
Primary ContactSujin Kim
Outcome results
None listed