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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.

Primary Purpose

Diabetic Peripheral Angiopathy

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renexin CR 200/160mg
Aspirin 100mg
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Angiopathy

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

<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

Sites / Locations

  • SK chemicalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Renexin CR 200/160mg

Aspirin 100mg

Arm Description

Single oral administration of Renexin CR 200/160mg, QD

Single oral administration of Aspirin 100mg, QD

Outcomes

Primary Outcome Measures

Changes in carotid IMT
Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05906199
Brief Title
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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Angiopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renexin CR 200/160mg
Arm Type
Experimental
Arm Description
Single oral administration of Renexin CR 200/160mg, QD
Arm Title
Aspirin 100mg
Arm Type
Active Comparator
Arm Description
Single oral administration of Aspirin 100mg, QD
Intervention Type
Drug
Intervention Name(s)
Renexin CR 200/160mg
Other Intervention Name(s)
Renexin CR
Intervention Description
Single oral administration of Renexin CR 200/160mg, QD
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Other Intervention Name(s)
Aspirin
Intervention Description
Single oral administration of Aspirin 100mg, QD
Primary Outcome Measure Information:
Title
Changes in carotid IMT
Description
Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product
Time Frame
24weeks, 48weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
<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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sol-Ji Jung
Phone
010-9443-8833
Email
jungsolji@skdiscovery.com
Facility Information:
Facility Name
SK chemicals
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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