Clinical Trial for GNX80 in Intermittent Claudication

SK chemicals

Status and phase: Enrolling; Phase 4

Conditions: Intermittent Claudication

Treatments: Drug: GNX80; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05400395

GNX_001

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

GNX

Experimental group

Description:

GNX / 80mg / BID / PO

Treatment:

Drug: GNX80

Placebo

Placebo Comparator group

Description:

Placebo / BID / PO

Treatment:

Drug: Placebo