Status:
RECRUITING
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Daewon Pharmaceutical Co., Ltd.
Conditions:
Dyslipidemia
Atherosclerosis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.
Detailed Description
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be ev...
Eligibility Criteria
Inclusion
- Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit
- Male or female of 20 years or over
- Mixed dyslipidemia: triglyceride 200\~499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL
- Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
- Creatinine ≤1.8 mg/dL
Exclusion
- Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL
- Uncontrolled hypertension
- Severe renal dysfunction
- GOT/GPT \>120/120 or chronic liver disease
- Pregnant or childbearing woman who does not have enough contraception
- Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months
- Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05365425
Start Date
June 1 2023
End Date
December 31 2026
Last Update
May 1 2024
Active Locations (1)
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1
SNUBH
Seongnam-si, Gyeonggi-do, South Korea, 13620