Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02341716 - Hospital- and Home-based Supervised Exercise Versus UNsupervised Walk Advice For Patients With InTermittent Claudication N/A
Completed NCT02041169 - Lower Extremity Peripheral Arterial Disease and Exercise Ischemia N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Recruiting NCT00538408 - Whole Body Magnetic Resonance Angiography in Ischemic Patients N/A
Completed NCT00388128 - Caffeine and Intermittent Claudication Phase 3
Completed NCT00618670 - Home-based vs. Supervised Exercise for People With Claudication N/A
Recruiting NCT00146666 - Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD) Phase 2
Completed NCT00134277 - Trial Comparing Different Medical Devices for Infragenual Dilatation N/A
Completed NCT01256775 - Effect of NCX4016 on Walking Distance in Patients With Peripheral Arterial Occlusive Disease (PAOD) Phase 2
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Recruiting NCT06299956 - Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark N/A
Not yet recruiting NCT05335161 - A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease Phase 1
Completed NCT04390282 - Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication N/A
Completed NCT03271710 - Study to Evaluate the Lower Extremity Intervention With Integrated Embolic Protection Using the Vanguard IEP System N/A
Completed NCT02380794 - Novel Treatment of Intermittent Claudication in Patients With Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule Phase 2
Active, not recruiting NCT02276937 - Randomized Phase IIb Trial of DVC1-0101 Phase 2
Completed NCT02097082 - Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System N/A
Recruiting NCT00539266 - Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia Phase 2/Phase 3
Completed NCT00071266 - The Dose Response of Niacin ER/Lovastatin on Peak Walking Time (PWT) in Patients With Intermittent Claudication - TROPIC Phase 3
Completed NCT00300690 - Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp) Phase 4