Status:
UNKNOWN
High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes
Lead Sponsor:
Yuhan Corporation
Conditions:
Atherosclerotic Cardiovascular Disease
Type 2 Diabetes
Eligibility:
All Genders
40-74 years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes
Detailed Description
This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 10mg/ezetimibe 10mg) vs. rosuvastatin 20mg treated for 24 weeks in atherosclerotic cardiovascular disease risk (≥ 7.5%) pat...
Eligibility Criteria
Inclusion
- ≥ 40 and \< 75 years of age at the time of informed consent
- Estimated 10-year ASCVD (atherosclerotic cardiovascular disease) risk ≥ 7.5% with type 2 diabetes according to the American Diabetes Association criteria in screening
- HbA1c ≥ 6% and \< 10% in screening
- Body mass index (BMI) ≤ 35kg/m2 in screening
- Female of childbearing with a negative pregnancy test who must agree to use contraception (including those not medically pregnant) during the study period
- Written consent after being informed of the purpose and contents of the clinical trial and the characteristics and risks of IPs
- Exclusion Criteria:
- Type 1 diabetes
- Chronic hepatitis B or chronic hepatitis C, severe hepatic dysfunction (AST, ALT, ALP or CPK ≥ 3 x ULN) in screening
- Heavy drinking \> 210g per week in screening
- Estimated GFR \< 30mL/min/1.73m2 using the CKD-EPI formula in screening
- Undergoing renal replacement therapy (hemodialysis or peritoneal dialysis) in screening
- Having used other statin (HMG-CoA converting enzyme inhibitors) than Rosuvastatin or fibrate drugs in the last 3 months before screening
- Taking any medication (ex. Fenofibrate, Omega 3 fatty acid, etc.) that may affect LDL
- \* Can be enrolled after 4 week-washout
- Having used thiazolidinedione drugs in the last 3 months before screening
- Taking cyclosporine concomitantly
- Positive HIV test in screening
- Pregnant, breastfeeding, or childbearing women who are not likely to use the appropriate contraceptive methods as judged by investigator
- Subjects with a medical history of myopathy and rhabdomyolysis due to use of statin
- Hypersensitive to statin and ezetimibe
- Having endocrine or metabolic disease known to affect serum lipids or lipoproteins
- Uncontrolled diabetes (HbA1c ≥ 10%)
- Uncontrolled thyroid dysfunction (TSH ≥ 3 x ULN)
- Subjects with a medical history of acute arterial diseases such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous coronary intervention in the last 6 months before screening
- Subjects with a surgical history of gastrointestine or drug absorption disorders due to gastrointestinal disorders
- Insulin-treated
- Taking other IPs in the last 30 days before screening
- Subjects who cannot discontinue contraindications that may affect the treatment of all types of diabetes and/or hypercholesterolemia during the study period
- Subjects with a significant or unstable medical or psychological condition that is judged by investigator to be detrimental to safety or to successful participation in the trial
- Other conditions than the above who is deemed to be ineligible to participate in the trial by investigator
Exclusion
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03403556
Start Date
March 27 2018
End Date
December 1 2021
Last Update
December 14 2020
Active Locations (6)
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1
Daegu Catholic University Medical Center
Daegu, South Korea
2
Keimyung University Dongsan Medical Center
Daegu, South Korea
3
Kyungpook National University Hospital
Daegu, South Korea
4
Yeungnam University Medical Center
Daegu, South Korea