Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia (REMBRANDT)

August 10, 2025 updated by: Soo Heon Kwak, Seoul National University Hospital

A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetimiBe/Rosuvastatin Diabetic Dislipidemia With Hypertriglyceridaemia

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kyong Soo Park, Dr.
  • Phone Number: +82-2-2072-2946
  • Email: kspark@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Korea University Ansan Hospital
      • Bucheon, Korea, Republic of
        • Soon Chun Hyang University Hospital Bucheon
      • Cheonan, Korea, Republic of
        • Soon Chun Hyang University Hospital Cheonan
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Yeongnam University Medical Center
      • Daejeon, Korea, Republic of
        • Eulji University Hospital
      • Gangdong, Korea, Republic of
        • Kyung Hee University Hosipital at Gangdong
      • Goyang-si, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Guri-si, Korea, Republic of
        • Hanyang University Guri Hospital
      • Gwangju, Korea, Republic of
        • Chosun University Hospital
      • Hwaseong-si, Korea, Republic of
        • Hallym University Medical Center-Dongtan
      • Inchon, Korea, Republic of
        • Inha University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul St.Mary
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Gangnam Severance Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Suwon, Korea, Republic of
        • The Catholic University of Korea, St. Vincent'S Hospital
      • Sŏngnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Sŏngnam, Korea, Republic of
        • Gachon University, Donginchoen Gil Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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. Who have the following laboratory values on an empty stomach

    • Patients with no prior statin therapy

      • Low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are < 400 mg/dL)
      • 200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL

    • Patients currently receiving low- or moderate-intensity statin therapy

      • Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are < 400 mg/dL)

    • 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

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

    • Atherosclerotic disease occurring within 24 weeks at screening
    • Myopathy including rhabdomyolysis
    • 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
    • Major mental illness (depression, bipolar disorder, etc.)
    • Malignant tumor within 5 years at screening

  5. Persons with the following comorbidities and laboratory abnormalities

    • CK ≥ 2 X ULN
    • Patients with severe hepatopathy (AST or ALT > 5 X ULN)
    • Patients with unexplained persistent ALT elevation opinion or active liver disease
    • TSH (Thyroid stimulating hormone) > 1.5 X ULN or those who do not maintain stable thyroid stimulating hormone level by investigator's judgment
    • Uncontrolled hypertension (greater than sitBP 160/100 mmHg at screening)
    • 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

    • Non-statin lipid modulators
    • Foods or drugs that affect lipid control
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test group
Subject administered with Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Active Comparator: Control group
Subject administered with Suvast tablet 10 mg (Rosuvastatin 10 mg)
Drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
- Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
LDL-C change rate (percent, %)
Time Frame: Baseline and 16 weeks
To compare LDL-C change rate (percent, %) between test and control group
Baseline and 16 weeks
Triglyceride (TG) change rate (percent, %)
Time Frame: Baseline and 16 weeks
To compare Triglyceride (TG) change rate (percent,%)between test and control group
Baseline and 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change rates (percent, %) of LDL-C and Triglyceride (TG)
Time Frame: Baseline and 4 weeks
To measure/compare Change rates (percent, %) of LDL-C and Triglyceride (TG) between test and control group
Baseline and 4 weeks
Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C
Time Frame: Baseline, 4 weeks, and 16 weeks
To measure/compare Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C between test and control group
Baseline, 4 weeks, and 16 weeks
Percent (%) of subjects with a 50% or more reduction in LDL-C level
Time Frame: 4 weeks and 16 weeks
To measure/compare Percent (%) of subjects with a 50% or more reduction in LDL-C level between test and control group
4 weeks and 16 weeks
Percent (%) of subjects with LDL-C below 70 mg/dL
Time Frame: 4 weeks and 16 weeks
To measure/compare Percent (%) of subjects with LDL-C below 70 mg/dL between test and control group
4 weeks and 16 weeks
Changes of lipoproteins (ApoA1, ApoB)
Time Frame: Baseline and 16 weeks
To measure/compare Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL)) between test and control group
Baseline and 16 weeks
Changes of lipoproteins (ApoB/ApoA1 ratio)
Time Frame: Baseline and 16 weeks
To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group
Baseline and 16 weeks
Change of HOMA-IR
Time Frame: Baseline and 16 weeks
To measure/compare Change of HOMA-IR between test and control group
Baseline and 16 weeks
Change of HbA1C (percentage, %)
Time Frame: Baseline, 4 weeks, and 16 weeks
To measure/compare Change of HbA1C (percentage, %) between test and control group
Baseline, 4 weeks, and 16 weeks
Change (mg/dL) of Fasting Plasma Glucose (FPG)
Time Frame: Baseline, 4 weeks, and 16 weeks
To measure/compare Change (mg/dL) of Fasting Plasma Glucose (FPG) between test and control group
Baseline, 4 weeks, and 16 weeks
Change (mg/dL) of hs-CRP
Time Frame: Baseline and 16 weeks
To measure/compare Change (mg/dL) of hs-CRP between test and control group
Baseline and 16 weeks
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
Time Frame: Baseline and 16 weeks
To measure/compare 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 between test and control group
Baseline and 16 weeks
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)
Time Frame: Baseline and 16 weeks
To measure/compare 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) between test and control group
Baseline and 16 weeks
Adverse event
Time Frame: Baseline and 16 weeks
To measure/compare Adverse event between test and control group
Baseline and 16 weeks
Blood pressure
Time Frame: Baseline and 16 weeks
To measure/compare Blood pressure between test and control group
Baseline and 16 weeks
Pulse
Time Frame: Baseline and 16 weeks
To measure/compare Pulse between test and control group
Baseline and 16 weeks
Electrocardiogram (12-lead ECG)
Time Frame: -4 weeks and 16 weeks
Number(%) of participants with Clinically Significant or Normal Electrocardiogram (12-lead ECG) findings after study drug administration
-4 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gangnam Severance Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kyong Soo Park, Dr., Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REMBRANDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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