Clinical Trial for GNX80 in Intermittent Claudication

SK Chemicals Co., Ltd.120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Intermittent Claudication

Interventions

GNX80DRUG

GNX80 oral intake(BID) for 24 weeks

PlaceboDRUG

Placebo oral intake(BID) for 24 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Walking Distance in comparison with the findings from at baseline

walking distance evaluated by a constant treadmill test

Time frame: 24 weeks

Central Contacts

Sujin Kim

CONTACT

82-2-2008-2938 sujinkim@sk.com

Data from ClinicalTrials.gov

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