Clinical Trial for GNX80 in Intermittent Claudication

NCT ID: NCT05400395

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-08-31

Brief Summary

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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

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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

Conditions

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Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GNX

GNX / 80mg / BID / PO

Group Type EXPERIMENTAL

GNX80

Intervention Type DRUG

GNX80 oral intake(BID) for 24 weeks

Placebo

Placebo / BID / PO

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral intake(BID) for 24 weeks

Interventions

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GNX80

GNX80 oral intake(BID) for 24 weeks

Intervention Type DRUG

Placebo

Placebo oral intake(BID) for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Test Control

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sujin Kim

Role: CONTACT

82-2-2008-2938

Facility Contacts

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Seung-Woon Rha

Role: primary

Other Identifiers

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GNX_001

Identifier Type: -

Identifier Source: org_study_id

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