Clinical Trial for GNX80 in Intermittent Claudication | NCT05400395

Studies
Clinical Trial for GNX80 in Intermittent Claudication

NCT05400395

Sponsor

SK Chemicals Co., Ltd.

Status

Unknown status

Last Update Posted

Oct 27, 2022Actual

Enrollment

120Estimated

Phase

Phase 4

Conditions

Intermittent Claudication

Interventions

GNX80
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2022Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Aug 2024Estimated

First Submitted Date

May 27, 2022

First Submission Date that Met QC Criteria

May 27, 2022

First Posted Date

Jun 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2022

Last Update Posted Date

Oct 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GNX	Experimental	GNX / 80mg / BID / PO	Drug: GNX80
Placebo	Placebo Comparator	Placebo / BID / PO	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GNX80	Drug	GNX80 oral intake(BID) for 24 weeks	GNX	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Walking Distance in comparison with the findings from at baseline	walking distance evaluated by a constant treadmill test	24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sujin Kim	Contact	82-2-2008-2938		sujinkim@sk.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007383	Intermittent Claudication

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided