High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2021-12-31

Brief Summary

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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

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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%) patients with type 2 diabetes

Conditions

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Atherosclerotic Cardiovascular Disease Type 2 Diabetes

Keywords

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High ASCVD risk patients with type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvamibe ® Tab.

Rosuvastatin 10mg/Ezetimibe10mg

Group Type EXPERIMENTAL

Rosuvamibe

Intervention Type DRUG

Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks

Monorova ® Tab.

Rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

Monorova

Intervention Type DRUG

Rosuvastatin 20mg qd for 24 weeks

Interventions

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Rosuvamibe

Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks

Intervention Type DRUG

Monorova

Rosuvastatin 20mg qd for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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