NCT03403556

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

3.5 years

First QC Date

December 11, 2017

Last Update Submit

December 11, 2020

Conditions

Atherosclerotic Cardiovascular DiseaseType 2 Diabetes

Keywords

High ASCVD risk patients with type 2 diabetes

Outcome Measures

Primary Outcomes (1)

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

    Up to 24 weeks

Secondary Outcomes (12)

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 7.5% 10-year ASCVD risk without withdrawn due to adverse events

    Up to 24 weeks

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

    Up to 12 weeks, Up to 24 weeks

  • 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 80mg/dL) without withdrawn due to adverse events

    Up to 24 weeks

  • 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)

    Up to 24 weeks

  • Mean change from baseline to week 24 in Hepatic Steatosis Index (HSI)

    Up to 24 weeks

  • +7 more secondary outcomes

Study Arms (2)

Rosuvamibe ® Tab.

EXPERIMENTAL

Rosuvastatin 10mg/Ezetimibe10mg

Drug: Rosuvamibe

Monorova ® Tab.

ACTIVE COMPARATOR

Rosuvastatin 20mg

Drug: Monorova

Interventions

RosuvamibeDRUG

Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks

Rosuvamibe ® Tab.
MonorovaDRUG

Rosuvastatin 20mg qd for 24 weeks

Monorova ® Tab.

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Daegu Catholic University Medical Center

Daegu, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

NOT YET RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

NOT YET RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

RECRUITING

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

Gyeonggi-do, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

AtherosclerosisDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2017

First Posted

January 18, 2018

Study Start

March 27, 2018

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

December 14, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(6)