| Trial ID: | L4519 |
| Source ID: | NCT04700436
|
| Associated Drug: |
Rosuzet Tablet 10/5 Mg (Ezetimibe 10 Mg/Rosuvastatin 5 Mg)
|
| Title: |
Efficacy and Safety of EzetimiBe/Rosuvastatin in Diabetic Dislipidemia With Hypertriglyceridaemia
|
| Acronym: |
REMBRANDT
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Endocrine System Diseases|Nutritional and Metabolic Diseases|Diabetes Mellitus, Type 2|Dyslipidemias
|
| Interventions: |
DRUG: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
|
| Outcome Measures: |
Primary: LDL-C change rate (percent, %), To compare LDL-C change rate (percent, %) between test and control group, Baseline and 16 weeks|Triglyceride (TG) change rate (percent, %), To compare Triglyceride (TG) change rate (percent,%)between test and control group, Baseline and 16 weeks | Secondary: 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, Baseline and 4 weeks|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, Baseline, 4 weeks, and 16 weeks|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, 4 weeks and 16 weeks|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, 4 weeks and 16 weeks|Changes of lipoproteins (ApoA1, ApoB), 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), To measure/compare Changes of lipoproteins (ApoB/ApoA1 ratio) between test and control group, Baseline and 16 weeks|Change of HOMA-IR, To measure/compare Change of HOMA-IR between test and control group, Baseline and 16 weeks|Change of HbA1C (percentage, %), 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), 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, 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, 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), 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, To measure/compare Adverse event between test and control group, Baseline and 16 weeks|Blood pressure, To measure/compare Blood pressure between test and control group, Baseline and 16 weeks|Pulse, To measure/compare Pulse between test and control group, Baseline and 16 weeks|Electrocardiogram (12-lead ECG), Number(%) of participants with Clinically Significant or Normal Electrocardiogram (12-lead ECG) findings after study drug administration, -4 weeks and 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Hospital | Collaborators: Gangnam Severance Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
240
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-01-03
|
| Completion Date: |
2021-11-26
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| Results First Posted: |
|
| Last Update Posted: |
2021-01-07
|
| Locations: |
Korea University Ansan Hospital, Ansan, Korea, Republic of|Soon Chun Hyang University Hospital Bucheon, Bucheon, Korea, Republic of|The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea, Republic of|Soon Chun Hyang University Hospital Cheonan, Cheonan, Korea, Republic of|Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of|Yeongnam University Medical Center, Daegu, Korea, Republic of|Eulji University Hospital, Daejeon, Korea, Republic of|Kyung Hee University Hosipital at Gangdong, Gangdong, Korea, Republic of|Inje University Ilsan Paik Hospital, Goyang-si, Korea, Republic of|Myongji Hospital, Goyang-si, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Korea, Republic of|Chosun University Hospital, Gwangju, Korea, Republic of|Hallym University Medical Center-Dongtan, Hwaseong-si, Korea, Republic of|Inha University Hospital, Inchon, Korea, Republic of|Pusan National University Hospital, Pusan, Korea, Republic of|Korea University Anam Hospital, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|Kyung Hee University Hospital, Seoul, Korea, Republic of|Samsung Medical Center, Seoul, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|The Catholic University of Korea, Seoul St.Mary, Seoul, Korea, Republic of|The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, Korea, Republic of|Yonsei University Health System, Gangnam Severance Hospital, Seoul, Korea, Republic of|Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of|Ajou University Hospital, Suwon, Korea, Republic of|The Catholic University of Korea, St. Vincent's Hospital, Suwon, Korea, Republic of|Gachon University, Donginchoen Gil Hospital, Sŏngnam, Korea, Republic of|Seoul National University Bundang Hospital, Sŏngnam, Korea, Republic of
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| URL: |
https://clinicaltrials.gov/show/NCT04700436
|
