Back to resultsClinical Trial for GNX80 in Intermittent Claudication
Primary Purpose
Intermittent Claudication
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GNX80
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication
Eligibility Criteria
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
Sites / Locations
- Korea University Guro HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GNX
Placebo
Arm Description
GNX / 80mg / BID / PO
Placebo / BID / PO
Outcomes
Primary Outcome Measures
Walking Distance in comparison with the findings from at baseline
walking distance evaluated by a constant treadmill test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400395
Brief Title
Clinical Trial for GNX80 in Intermittent Claudication
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GNX
Arm Type
Experimental
Arm Description
GNX / 80mg / BID / PO
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo / BID / PO
Intervention Type
Drug
Intervention Name(s)
GNX80
Other Intervention Name(s)
Test
Intervention Description
GNX80 oral intake(BID) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Placebo oral intake(BID) for 24 weeks
Primary Outcome Measure Information:
Title
Walking Distance in comparison with the findings from at baseline
Description
walking distance evaluated by a constant treadmill test
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sujin Kim
Phone
82-2-2008-2938
Email
sujinkim@sk.com
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Woon Rha
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial for GNX80 in Intermittent Claudication
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