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A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetiMiBe/Rosuvastatin 10/5 mg Composite Pack from RosuvAstatiN 10 mg in Diabetic dislipidemia with HyperTriglyceridaemia (REMBRANDT)

Status Approved

  • First Submitted Date

    2019/12/10

  • Registered Date

    2019/12/23

  • Last Updated Date

    2019/12/26

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0004577
    Unique Protocol ID REMBRANDT
    Public/Brief Title A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetiMiBe/Rosuvastatin 10/5 mg Composite Pack from RosuvAstatiN 10 mg in Diabetic dislipidemia with HyperTriglyceridaemia (REMBRANDT)
    Scientific Title A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetiMiBe/Rosuvastatin 10/5 mg Composite Pack from RosuvAstatiN 10 mg in Diabetic dislipidemia with HyperTriglyceridaemia (REMBRANDT)
    Acronym REMBRANDT
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number MJH2019-10-010
    Approval Date 2019-10-30
    Institutional Review Board Name Myongji Hospital Institutional Reveiw Board
    Institutional Review Board Address 55, Hwasu-ro 14beon-gil, Deogyang-gu, Goyang-si, Gyeonggi-do
    Institutional Review Board Telephone 031-810-5457
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kyong Soo Park
    Title Professor
    Telephone +82-2-2072-2946
    Affiliation Seoul National University Hospital
    Address 101, DAEHAK-RO JONGNO-GU, SEOUL
    Contact Person for Public Queries
    Name Insuk Ha
    Title CRC
    Telephone +82-2-2072-1673
    Affiliation Seoul National University Hospital
    Address 101, DAEHAK-RO JONGNO-GU, SEOUL
    Contact Person for Updating Information
    Name Insuk Ha
    Title CRC
    Telephone +82-2-2072-1673
    Affiliation Seoul National University Hospital
    Address 101, DAEHAK-RO JONGNO-GU, SEOUL

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 29
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 Anticipated
    Target Number of Participant 240
    Primary Completion Date 2021-05-28 , Anticipated
    Study Completion Date 2021-11-26 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Koera University Guro Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Kyung Hee University Hospital at Gangdong
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Kyung Hee University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Daegu Catholic University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Eulji University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Korea University Anam Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Hallym University Medical Center-Dongtan
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Myongji Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Pusan National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 12
    Name of Study The Catholic University of Korea, Bucheon St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Seoul National University Bundang Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Samsung Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 15
    Name of Study Seoul National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 16
    Name of Study Korea University Ansan Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 17
    Name of Study The Catholic University of Korea, St. Vincent's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 18
    Name of Study Soon Chun Hyang University Hospital Bucheon
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 19
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 20
    Name of Study Ajou University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 21
    Name of Study The Catholic University of Korea, Yeouido St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 22
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 23
    Name of Study Yeongnam University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 24
    Name of Study Gachon University, Donginchoen Gil Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 25
    Name of Study Inha University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 26
    Name of Study Inje University Ilsan Paik Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 27
    Name of Study Chosun University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 28
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,
    Recruitment Status by Participating Study Site 29
    Name of Study Hanyang University Guri Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-01-03 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hanmi Pharm
    Organization Type Pharmaceutical Company
    Project ID REMBRANDT

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    IMPROVE-IT study of patients with acute cardiovascular disease showed that incidence of cardiovascular disease was further reduced by 2% over 7 years by Ezetimibe/Statin combination therapy (Ezetimibe 10 mg/Simvastatin 40 mg) compared to Statin monotherapy (Simvastatin 40 mg). In addition, both LDL-C and TG were significantly reduced, and the study’s subgroup analysis of diabetes patients showed a significant difference in the incidence of cardiovascular disease between the two groups.
Therefore, in this clinical trial, we want to compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Phase4
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description 
    1) Drugs
① Drug for Run-in: Suvast tablet 5 mg (Rosuvastatin)
② IP
- Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
2) Treatment period 
① Drug for Run-in: 4 weeks or more (up to 5 weeks)
② IP: 16 weeks
3) How to use
① Drug for Run-in: 1 tablet, orally once a day
② IP: 1 tablet, orally once a day
4) Open-label study
    Number of Arms 2
    Arm 1

    Arm Label

    Test group

    Target Number of Participant

    120

    Arm Type

    Experimental

    Arm Description

    After taking 1 tablet of Suvast tablet 5 mg (Rosuvastatin 5 mg) orally once a day for 4 weeks or more (up to 5 weeks), Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) is administered orally once a day for 16 weeks.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    120

    Arm Type

    Active comparator

    Arm Description

    After taking 1 tablet of Suvast tablet 5 mg (Rosuvastatin 5 mg) orally once a day for 4 weeks or more (up to 5 weeks), Suvast tablet 10 mg (Rosuvastatin 10 mg) is administered orally once a day for 16 weeks.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E78.5)Hyperlipidaemia, unspecified 

    Diabetes Mellitus type 2, Dyslipidemia with Hypertriglyceridemia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    40Year~75Year

    Description

    Screening (Visit 1) Inclusion Criteria
1) Korean men and women aged 40 to 75
2) Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
3) Those who have no history of statin administration or who are receiving low- and moderate-intensity statin, and who have the following laboratory values on an empty stomach 
- Low density lipoprotein-cholesterol (LDL-C) ≥ 100 mg/dL (direct measurement result)
- 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
4) Those with less than 9% HbA1C
5) Those who voluntarily agreed to participate in this clinical trial and signed a written ICF

Randomization (Visit 2) Inclusion Criteria
1) Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment
2) LDL-C ≥ 70 mg/dL (direct measurement result) at baseline (visit 2)
3) Triglyceride (TG) ≥ 150 mg/dL at baseline (visit 2)
    Exclusion Criteria 
    1) Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
2) Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial
3) Patients with Body Mass Index (BMI) < 15 kg/ m2 or > 35 kg/m2 
4) Persons with the following medical history or surgical/interventional history
① Atherosclerotic disease occurring within 24 weeks at screening
② Myopathy including rhabdomyolysis
③ Patients who have had a history of drug or alcohol abuse, or who have met drug or alcohol abuse criteria within 1 year at screening 
④ Major mental illness (depression, bipolar disorder, etc.)
⑤ Malignant tumor within 5 years at screening
5) Persons with the following comorbidities and laboratory abnormalities
① CK ≥ 2 X ULN
② Patients with severe hepatopathy (AST of ALT > 5 X ULN)
③ Patients with unexplained persistent ALT elevation opinion or active liver disease
④ TSH (Thyroid stimulating hormone) > 1.5 X ULN or those who do not maintain stable thyroid stimulating hormone level by investigator’s judgment
⑤ Uncontrolled hypertension (greater than sitBP 160/100 mmHg at screening)
⑥ Renal disorder patients with severe renal failure (creatinine clearance (CLcr) <30 mL/min)
6) Those who have the following history of drug administration within 3 months at screening
① Non-statin lipid modulators
② Foods or drugs that affect lipid control
③ Systemic steroids
7) Those who are expected to administer contraindication drugs during clinical trial, including screening
8) Those who have persistent history of drinking within 1 week at clinical trial participation or who are unable to perform TLC due to continuous drinking during clinical trial
9) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
10) Those who received other IPs or investigational medical devices within 30 days at screening
11) Patients judged to be ineligible to participate in clinical trial by investigator’s decision
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome 
    LDL-C change rate (%)
    Timepoint 
    Baseline and 16 weeks
    Primary Outcome(s) 2
    Outcome 
    Triglyceride (TG) change rate (%)
    Timepoint 
    Baseline and 16 weeks
    Secondary Outcome(s) 1
    Outcome 
    Change rates (%) of LDL-C and Triglyceride (TG)
    Timepoint 
    Baseline and 4 weeks
    Secondary Outcome(s) 2
    Outcome 
    Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C
    Timepoint 
    Baseline, 4 weeks, and 16 weeks
    Secondary Outcome(s) 3
    Outcome 
    Percentage (%) of subjects with a 50% or more reduction in LDL-C level
    Timepoint 
    Baseline, 4 weeks, and 16 weeks
    Secondary Outcome(s) 4
    Outcome 
    Percentage (%) of subjects with LDL-C below 70 mg/dL
    Timepoint 
    4 weeks and 16 weeks
    Secondary Outcome(s) 5
    Outcome 
    Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL), ApoB/ApoA1 Ratio)
    Timepoint 
    Baseline and 16 weeks
    Secondary Outcome(s) 6
    Outcome 
    Change of HOMA-IR
    Timepoint 
    Baseline and 16 weeks
    Secondary Outcome(s) 7
    Outcome 
    Change of HbA1C (%)
    Timepoint 
    Baseline, 4 weeks, and 16 weeks
    Secondary Outcome(s) 8
    Outcome 
    Change (mg/dL) of Fasting Plasma Glucose (FPG)
    Timepoint 
    Baseline, 4 weeks, and 16 weeks
    Secondary Outcome(s) 9
    Outcome 
    Change (mg/dL) of hs-CRP
    Timepoint 
    Baseline and 16 weeks
    Secondary Outcome(s) 10
    Outcome 
    Changes of plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL) levels at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC
    Timepoint 
    Baseline and 16 weeks
    Secondary Outcome(s) 11
    Outcome 
    On the graphs at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC, total Area Under the Curve (tAUC) of each plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL)
    Timepoint 
    Baseline and 16 weeks
    Secondary Outcome(s) 12
    Outcome 
    Adverse event, laboratory tests, vital signs (blood pressure, pulse rate)
    Timepoint 
    Every visits
    Secondary Outcome(s) 13
    Outcome 
    Electrocardiogram (12-lead ECG)
    Timepoint 
    -4 weeks and 16 weeks

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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