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Status unknownNCT03403556Updated Dec 14, 2020

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

A Phase 4 interventional study of Rosuvamibe and Monorova in Atherosclerotic Cardiovascular Disease and Type 2 Diabetes, sponsored by Yuhan Corporation. Status unknown at 6 sites in Korea, Republic of. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2020-12-14.

Sponsored by Yuhan Corporation · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
40 Years to 74 Years
Sex
All
01

Study 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

Read the 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%) patients with type 2 diabetes

02

Conditions studied

  • Atherosclerotic Cardiovascular Disease
  • Type 2 Diabetes

Keywords

  • High ASCVD risk patients with type 2 diabetes
03

Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • ≥ 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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Rosuvamibe ® Tab.

    Rosuvastatin 10mg/Ezetimibe10mg

    Drug: Rosuvamibe

  • Active comparator
    Monorova ® Tab.

    Rosuvastatin 20mg

    Drug: Monorova

Interventions

  • DrugRosuvamibe

    Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks

  • DrugMonorova

    Rosuvastatin 20mg qd for 24 weeks

05

What researchers measure

Primary outcomes

  1. Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C)

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Proportion of subjects achieving < 7.5% 10-year ASCVD risk without withdrawn due to adverse events

    Time frame: Up to 24 weeks

  2. Mean change from baseline to week 12 and to week 24 in 10-year ASCVD risk

    Time frame: Up to 12 weeks, Up to 24 weeks

  3. Proportion of subjects achieving the comprehensive lipid target (LDL-C < 70mg/dL, Non-HDL-C < 100mg/dL, and Apolipoprotein B < 80mg/dL) without withdrawn due to adverse events

    Time frame: Up to 24 weeks

  4. Mean change from baseline to week 24 in calculated LDL cholesterol(mg/dL), HDL cholesterol(mg/dL), Triglyceride(mg/dL), non-HDL cholesterol(mg/dL), Apolipoprotein B(mg/dL), Apolipoprotein A1(mg/dL)

    Time frame: Up to 24 weeks

  5. Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)

    hepatic steatosis index (HSI)= 8x(ALT/AST ratio)+BMI (+2, if female; +2, if diabetes mellitus)

    Time frame: Up to 24 weeks

  6. Mean change from baseline to week 24 in Fatty Liver Index (FLI)

    FLI scores will be calculated based on triglycerides, BMI, r-GT and Waist circumference. BMI(kg/m\^2) will be calculated based on height(m) and weight(kg).

    Time frame: Up to 24 weeks

  7. Mean change from baseline to week 24 in non-alcoholic fatty liver disease liver fat score (NAFLD-LFS)

    Time frame: Up to 24 weeks

  8. Mean change from baseline to week 24 in HbA1c

    Time frame: Up to 24 weeks

  9. Mean change from baseline to week 24 in fasting plasma glucose (FPG)

    Time frame: Up to 24 weeks

  10. Mean change from baseline to week 24 in sCD36

    Time frame: Up to 24 weeks

  11. Mean change from baseline to week 24 in HOMA-IR

    Time frame: Up to 24 weeks

  12. Mean change from baseline to week 24 in HOMA-B

    Time frame: Up to 24 weeks

06

Study locations

1 of 6 sites recruiting
  • Daegu Catholic University Medical Center
    Daegu, Korea, Republic of
    Not yet recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, Korea, Republic of
    Not yet recruiting
  • Kyungpook National University Hospital
    Daegu, Korea, Republic of
    Not yet recruiting
  • Yeungnam University Medical Center
    Daegu, Korea, Republic of
    Recruiting
  • The Catholic University of Korea, St. Vincent's Hospital
    Gyeonggi-do, Korea, Republic of
    Not yet recruiting
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03403556
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Mar 27, 2018
Primary completion
Oct 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Dec 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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