Diabetic Peripheral AngiopathyPhase 4NCT05906199
A Study to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract and Aspirin in Diabetic Peripheral Angiopathy.
A Phase 4 study testing Renexin CR 200/160mg and Aspirin 100mg in people with Diabetic Peripheral Angiopathy, run by SK Chemicals Co., Ltd. at 2 sites in South Korea.
Trial summary
This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Diabetic Peripheral Angiopathy
- What is being tested?
- Renexin CR 200/160mg and Aspirin 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 28 Jul 2021to 13 Dec 2023
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
<Inclusion Criteria>
- Male or female aged between 20 years and 75 years(inclusive)
- Patients who diagnosed as type 2 diabetes and diabetic peripheral angiopathy
- Patients with a maximum intra-carotid membrane thickness (maximum IMT) of 0.9 mm or more among the thickest areas, including plaques, in the CCA, ICA, and Bulb three areas of the carotid artery
<Exclusion Criteria>
- Patients who diagnosed with type 1 diabetes, secondary diabetes, or gestational diabetes
- Patients with cerebrovascular or cardiovascular complications within 6 months of screening (cerebral infarction, transient ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft(CABG), PCI, etc.)
- Patients with bleeding (hemophilia, capillary weakness, intracranial hemorrhage, upper digestive tract hemorrhage, urinary tract hemorrhage, hematopoietic hemorrhage, active digestive ulcers, etc.) or peptic ulcers within 3 months of screening
- Patient who took anticoagulants, antiplatelet drugs including aspirin, cilostazol, thrombolytic agents, prostaglandin E1 and glucagon-like peptide -1 (GLP-1) receptor agonist within 2 weeks of the baseline
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
SKChemicals
Seongnam, Gyunggi-do
SK chemicals
Seoul, 110-744
About this study
Official title: A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV, Exploratory Clinical Trial to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract (Renexin CR) and Aspirin (Aspirin Protect Tab.) in Diabetic Peripheral Angiopathy.
This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.
Read the detailed description
A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV
- Conditions
- Diabetic Peripheral Angiopathy
- Being tested
- Renexin CR 200/160mg, Aspirin 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renexin CR 200/160mgDrug
Also called Renexin CR
Single oral administration of Renexin CR 200/160mg, QD
Aspirin 100mgDrug
Also called Aspirin
Single oral administration of Aspirin 100mg, QD
| Study group | Role | What they receive |
|---|---|---|
| Renexin CR 200/160mg | Experimental | Single oral administration of Renexin CR 200/160mg, QD Receives: Drug: Renexin CR 200/160mg |
| Aspirin 100mg | Active comparator | Single oral administration of Aspirin 100mg, QD Receives: Drug: Aspirin 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in carotid IMT
Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product
Measured: 24weeks, 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start28 Jul 2021
- Primary completion23 Jun 2023
- Study completion13 Dec 2023
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 Diabetic Peripheral AngiopathyStudies 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
- None (open label)
- Enrolment
- 105 participants (actual)
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
- NCT05906199
- Sponsor's protocol ID
- RNX_001
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang YC, Kim MK, Park JH, Yun HM, Kim SY, Lim S. Comparison of Efficacy and Safety of Cilostazol/Extract of Ginkgo biloba vs. Aspirin in Carotid Atherosclerosis in Patients with Diabetes Mellitus. Diabetes Metab J. 2026 Mar;50(2):357-367. doi: 10.4093/dmj.2025.0146. Epub 2025 Aug 13.
PubMed 40803668
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV, Exploratory Clinical Trial to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract (Renexin CR) and Aspirin (Aspirin Protect Tab.) in Diabetic Peripheral Angiopathy.
- ClinicalTrials.gov ID
- NCT05906199
- Acronym / sponsor ID
- RNX_001
- Conditions
- Diabetic Peripheral Angiopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 15 Jun 2023 (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 study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.
Detailed description
A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renexin CR 200/160mg | Experimental | Drug: Renexin CR 200/160mgSingle oral administration of Renexin CR 200/160mg, QD |
| Aspirin 100mg | Active comparator | Drug: Aspirin 100mgSingle oral administration of Aspirin 100mg, QD |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Renexin CR 200/160mgAlso: Renexin CRSingle oral administration of Renexin CR 200/160mg, QD | Drug | Renexin CR 200/160mg |
| Aspirin 100mgAlso: AspirinSingle oral administration of Aspirin 100mg, QD | Drug | Aspirin 100mg |
Primary outcome
Changes in carotid IMT
Time frame: 24weeks, 48weeks
Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 40803668Hwang YC, Kim MK, Park JH, Yun HM, Kim SY, Lim S. Comparison of Efficacy and Safety of Cilostazol/Extract of Ginkgo biloba vs. Aspirin in Carotid Atherosclerosis in Patients with Diabetes Mellitus. Diabetes Metab J. 2026 Mar;50(2):357-367. doi: 10.4093/dmj.2025.0146. Epub 2025 Aug 13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Renexin CR 200/160mg and Aspirin 100mg in people with Diabetic Peripheral Angiopathy, run by SK Chemicals Co., Ltd. at 2 sites 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?
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: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in carotid IMT (time frame: 24weeks, 48weeks). 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 NCT05906199, 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 12 Mar 2025.