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Atherosclerotic Cardiovascular DiseasePhase 4NCT03403556

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

A Phase 4 study testing Rosuvamibe and Monorova in people with Atherosclerotic Cardiovascular Disease and Type 2 Diabetes, run by Yuhan Corporation at 6 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 40 to 74 years
What is being tested?
Rosuvamibe and Monorova
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
6 sitesSouth Korea
Study dates
27 Mar 2018to Dec 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites, 6 recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Not yet recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Not yet recruiting

  • Kyungpook National University Hospital

    Daegu

    Not yet recruiting

  • Yeungnam University Medical Center

    Daegu

    Kyuchang Won, 53-620-3846 ext. 82, kcwon@med.yu.ac.kr

    Recruiting

  • The Catholic University of Korea, St. Vincent's Hospital

    Gyeonggi-do

    Not yet recruiting

  • Korea University Anam Hospital

    Seoul

    Not yet recruiting

Other trials in South Korea

About this study

Official title: A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety Between High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in High ASCVD Risk Patients With Type 2 diabEtes (CREATE Study)

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

Being tested
Rosuvamibe, Monorova
Keywords
High ASCVD risk patients with type 2 diabetes
Medical subject headings
Atherosclerosis, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosuvamibeDrug

    Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks

  • MonorovaDrug

    Rosuvastatin 20mg qd for 24 weeks

Study groups in NCT03403556
Study groupRoleWhat they receive
Rosuvamibe ® Tab.ExperimentalRosuvastatin 10mg/Ezetimibe10mg
Receives: Drug: Rosuvamibe
Monorova ® Tab.Active comparatorRosuvastatin 20mg
Receives: Drug: Monorova

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 24 weeks

Secondary outcomes (12)

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

    Measured: Up to 24 weeks

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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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).

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

  8. Mean change from baseline to week 24 in HbA1c

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

  10. Mean change from baseline to week 24 in sCD36

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

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

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2018
  2. Study start27 Mar 2018
  3. Primary completionOct 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403556
Sponsor's protocol ID
CREATE
Status last verified
Dec 2020
First submitted
11 Dec 2017
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvamibe and Monorova in people with Atherosclerotic Cardiovascular Disease and Type 2 Diabetes, run by Yuhan Corporation at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean percent change from baseline to week 24 in low-density lipoprotein cholesterol (LDL-C) (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.

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