Intermittent ClaudicationPhase 4NCT05400395
Clinical Trial for GNX80 in Intermittent Claudication
A Phase 4 study testing GNX80 in people with Intermittent Claudication, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- GNX80
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2022to Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 20 years
- Angiographically confirmed peripheral arterial disease
- Intermittent claudication for more than 6 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Seung-Woon Rha
About this study
Official title: 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
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.
Read the 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
- Conditions
- Intermittent Claudication
- Being tested
- GNX80, Placebo
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNX80Drug
Also called Test
GNX80 oral intake(BID) for 24 weeks
PlaceboDrug
Also called Control
Placebo oral intake(BID) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| GNX | Experimental | GNX / 80mg / BID / PO Receives: Drug: GNX80 |
| Placebo | Placebo comparator | Placebo / BID / PO Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Distance in comparison with the findings from at baseline
walking distance evaluated by a constant treadmill test
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start5 Sep 2022
- Primary completionMar 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400395
- Sponsor's protocol ID
- GNX_001
- Status last verified
- Oct 2022
- First submitted
- 27 May 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim O, Lee SH, Kim JY, Kim W, Lee HC, Roh JW, Joh JH, Park SH, Shin S, Md SP, Kim W, Ahn HJ, Lee HK, Kim SH, Her SH, Rha SW, Yu CW. Efficacy and Safety of GNX80 in Patients with Peripheral Arterial Disease and Intermittent Claudication. Korean Circ J. 2026 Aug 24. doi: 10.4070/kcj.2026.0176. Online ahead of print.
PubMed 42773919
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05400395
- Acronym / sponsor ID
- GNX_001
- Conditions
- Intermittent Claudication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNX | Experimental | Drug: GNX80GNX / 80mg / BID / PO |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo / BID / PO |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of at least 20 years
- Angiographically confirmed peripheral arterial disease
- Intermittent claudication for more than 6 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNX80Also: TestGNX80 oral intake(BID) for 24 weeks | Drug | GNX |
| PlaceboAlso: ControlPlacebo oral intake(BID) for 24 weeks | Drug | Placebo |
Primary outcome
Walking Distance in comparison with the findings from at baseline
Time frame: 24 weeks
walking distance evaluated by a constant treadmill test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 42773919Kim O, Lee SH, Kim JY, Kim W, Lee HC, Roh JW, Joh JH, Park SH, Shin S, Md SP, Kim W, Ahn HJ, Lee HK, Kim SH, Her SH, Rha SW, Yu CW. Efficacy and Safety of GNX80 in Patients with Peripheral Arterial Disease and Intermittent Claudication. Korean Circ J. 2026 Aug 24. doi: 10.4070/kcj.2026.0176. Online ahead of print.
Related trials for Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GNX80 in people with Intermittent Claudication, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujin Kim (82-2-2008-2938, sujinkim@sk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Distance in comparison with the findings from at baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.