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Endocrine System DiseasesPhase 4REMBRANDTNCT04700436

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

A Phase 4 study testing Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) and Suvast tablet 10 mg (Rosuvastatin 10 mg) in people with Endocrine System Diseases and Nutritional and Metabolic Diseases, run by Seoul National University Hospital at 26 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) and Suvast tablet 10 mg (Rosuvastatin 10 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
26 sitesSouth Korea
Study dates
3 Jan 2020to 13 Feb 2024
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Screening (Visit 1) Inclusion Criteria
  • Korean men and women aged 40 to 75
  • Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
  • 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)
Show all 14Show fewer
  • 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
  • Those with less than 9% HbA1C
  • 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

Who cannot join

  • Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
  • Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial
  • Patients with Body Mass Index (BMI) < 15 kg/ m2 or > 35 kg/m2
  • Persons with the following medical history or surgical/interventional history
  • Atherosclerotic disease occurring within 24 weeks at screening
  • Myopathy including rhabdomyolysis
Show all 25Show fewer
  • 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
  • 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
  • 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
  • Those who are expected to administer contraindication drugs during clinical trial, including screening
  • 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
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
  • Those who received other IPs or investigational medical devices within 30 days at screening
  • Patients judged to be ineligible to participate in clinical trial by investigator's decision

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

South Korea26 sites

  • Korea University Ansan Hospital

    Ansan

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

  • Keimyung University Dongsan Medical Center

    Daegu

  • Yeongnam University Medical Center

    Daegu

  • Eulji University Hospital

    Daejeon

  • Kyung Hee University Hosipital at Gangdong

    Gangdong

  • Inje University Ilsan Paik Hospital

    Goyang-si

  • Hanyang University Guri Hospital

    Guri-si

  • Chosun University Hospital

    Gwangju

  • Hallym University Medical Center-Dongtan

    Hwaseong-si

  • Inha University Hospital

    Inchon

  • Pusan National University Hospital

    Pusan

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung Hee University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • The Catholic University of Korea, Seoul St.Mary

    Seoul

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

    Seoul

  • Yonsei University Health System, Gangnam Severance Hospital

    Seoul

  • Yonsei University Health System, Severance Hospital

    Seoul

  • Gachon University, Donginchoen Gil Hospital

    Sŏngnam

  • Seoul National University Bundang Hospital

    Sŏngnam

  • Ajou University Hospital

    Suwon

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

    Suwon

Other trials in South Korea

About this study

Official title: 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).

Read the 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).

Being tested
Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg), Suvast tablet 10 mg (Rosuvastatin 10 mg)
Medical subject headings
Endocrine System Diseases, Nutritional and Metabolic Diseases, Diabetes Mellitus, Type 2, Dyslipidemias

What participants receive

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

  • Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)Drug

    Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)

  • Suvast tablet 10 mg (Rosuvastatin 10 mg)Drug

    • Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)
Study groups in NCT04700436
Study groupRoleWhat they receive
Test groupExperimentalSubject administered with Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Receives: Drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
Control groupActive comparatorSubject administered with Suvast tablet 10 mg (Rosuvastatin 10 mg)
Receives: Drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)

What is being measured

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

  1. LDL-C change rate (percent, %)

    To compare LDL-C change rate (percent, %) between test and control group

    Measured: Baseline and 16 weeks

  2. Triglyceride (TG) change rate (percent, %)

    To compare Triglyceride (TG) change rate (percent,%)between test and control group

    Measured: Baseline and 16 weeks

Secondary outcomes (16)

  1. Change rates (percent, %) of LDL-C and Triglyceride (TG)

    To measure/compare Change rates (percent, %) of LDL-C and Triglyceride (TG) between test and control group

    Measured: Baseline and 4 weeks

  2. Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C

    To measure/compare Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C between test and control group

    Measured: Baseline, 4 weeks, and 16 weeks

  3. Percent (%) of subjects with a 50% or more reduction in LDL-C level

    To measure/compare Percent (%) of subjects with a 50% or more reduction in LDL-C level between test and control group

    Measured: 4 weeks and 16 weeks

  4. Percent (%) of subjects with LDL-C below 70 mg/dL

    To measure/compare Percent (%) of subjects with LDL-C below 70 mg/dL between test and control group

    Measured: 4 weeks and 16 weeks

  5. Changes of lipoproteins (ApoA1, ApoB)

    To measure/compare Changes of lipoproteins (ApoA1 (mg/dL), ApoB (mg/dL)) between test and control group

    Measured: Baseline and 16 weeks

  6. Changes of lipoproteins (ApoB/ApoA1 ratio)

    To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group

    Measured: Baseline and 16 weeks

  7. Change of HOMA-IR

    To measure/compare Change of HOMA-IR between test and control group

    Measured: Baseline and 16 weeks

  8. Change of HbA1C (percentage, %)

    To measure/compare Change of HbA1C (percentage, %) between test and control group

    Measured: Baseline, 4 weeks, and 16 weeks

  9. Change (mg/dL) of Fasting Plasma Glucose (FPG)

    To measure/compare Change (mg/dL) of Fasting Plasma Glucose (FPG) between test and control group

    Measured: Baseline, 4 weeks, and 16 weeks

  10. Change (mg/dL) of hs-CRP

    To measure/compare Change (mg/dL) of hs-CRP between test and control group

    Measured: Baseline and 16 weeks

  11. 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

    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

    Measured: Baseline and 16 weeks

  12. 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)

    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

    Measured: Baseline and 16 weeks

  13. Adverse event

    To measure/compare Adverse event between test and control group

    Measured: Baseline and 16 weeks

  14. Blood pressure

    To measure/compare Blood pressure between test and control group

    Measured: Baseline and 16 weeks

  15. Pulse

    To measure/compare Pulse between test and control group

    Measured: Baseline and 16 weeks

  16. Electrocardiogram (12-lead ECG)

    Number(%) of participants with Clinically Significant or Normal Electrocardiogram (12-lead ECG) findings after study drug administration

    Measured: -4 weeks and 16 weeks

Timeline

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

  1. First posted7 Jan 2021
  2. Study start3 Jan 2020
  3. Primary completion28 May 2021
  4. Study completion13 Feb 2024

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
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700436
Sponsor's protocol ID
REMBRANDT
Acronym
REMBRANDT
Status last verified
Jul 2025
First submitted
5 Oct 2020
Last updated
14 Aug 2025
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 Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) and Suvast tablet 10 mg (Rosuvastatin 10 mg) in people with Endocrine System Diseases and Nutritional and Metabolic Diseases, run by Seoul National University Hospital at 26 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 14 inclusion and 25 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: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C change rate (percent, %) (time frame: Baseline and 16 weeks). The study lists 2 primary outcomes in all. 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 NCT04700436.

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 Aug 2025.

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