NCT05400395

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

May 27, 2022

Last Update Submit

October 24, 2022

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

  • Walking Distance in comparison with the findings from at baseline

    walking distance evaluated by a constant treadmill test

    24 weeks

Study Arms (2)

GNX

EXPERIMENTAL

GNX / 80mg / BID / PO

Drug: GNX80

Placebo

PLACEBO COMPARATOR

Placebo / BID / PO

Drug: Placebo

Interventions

GNX80DRUG

GNX80 oral intake(BID) for 24 weeks

Also known as: Test
GNX
PlaceboDRUG

Placebo oral intake(BID) for 24 weeks

Also known as: Control
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of at least 20 years
  • Angiographically confirmed peripheral arterial disease
  • Intermittent claudication for more than 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sujin Kim

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

September 5, 2022

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations

KR(1)