NCT05906199CompletedPhase 4
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Changes in carotid IMT
Study Overview
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.
Detailed Description
A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Renexin CR 200/160mg
Experimental
Single oral administration of Renexin CR 200/160mg, QD
Intervention: Renexin CR 200/160mg (Drug)
Aspirin 100mg
Active Comparator
Single oral administration of Aspirin 100mg, QD
Intervention: Aspirin 100mg (Drug)
Outcomes
Primary Outcomes
Changes in carotid IMT
Time Frame: 24weeks, 48weeks
Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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