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NCT05400395 Clinical Trial

Clinical Trial for GNX80 in Intermittent Claudication

Intermittent Claudication Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05400395
Other study ID # GNX_001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 5, 2022
Est. completion date August 2024

Study information
Verified date October 2022
Source SK Chemicals Co., Ltd.
Contact Sujin Kim
Phone 82-2-2008-2938
Email sujinkim@sk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date August 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GNX80
GNX80 oral intake(BID) for 24 weeks
• Placebo
Placebo oral intake(BID) for 24 weeks

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
SK Chemicals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Walking Distance in comparison with the findings from at baseline walking distance evaluated by a constant treadmill test 24 weeks
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