Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM

NCT03597412 | Completed Phase 4

• 1 other identifier: YMC038
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus

Conditions

Atherosclerotic Cardiovascular Disease; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 24 in LDL-C level

  Baseline, Week 24

Secondary Outcomes (10)

• Change from baseline to week 12 in LDL-C level

  Baseline, Week 12

• Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)

  Baseline, Week 12, Week 24

• Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)

  Baseline, Week 12, Week 24

• Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1

  Baseline, Week 24

• Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)

  Baseline, Week 12, Week 24

Study Arms (2)

Rosuvamibe Tab

EXPERIMENTAL

Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks

Drug: Rosuvamibe

Monorova Tab

ACTIVE COMPARATOR

Rosuvastatin 20mg qd for 24 weeks

Drug: Monorova

Interventions

Rosuvamibe DRUG

Rosuvastatin 10mg/Ezetimibe 10mg

Rosuvamibe Tab

Monorova DRUG

Rosuvastatin 20mg

Monorova Tab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19 and above
• Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
• Patient diagnosed with ASCVD
• Myocardial Infarction (MI)
• Acute coronary syndrome (ACS)
• History of Coronary revascularization(Percutaneous Coronary Intervention, PCI)
• History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures
• Stroke or Transient ischemic attack (TIA)
• Peripheral Arterial Disease (PAD)
• Stable Angina
• Written informed consent

You may not qualify if:

• Type 1 diabetes
• HbA1c \> 8.5% at screening
• Fasting triglyceride ≥ 400 mg/dL at screening
• History of muscular disease or rhabdomyolysis due to use of statin
• Hypersensitive to rosuvastatin or ezetemibe
• Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
• ① Severe renal disease (CrCL \< 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) \< 30mL/min/1.73m2)
• ② ALT, AST \> 3x ULN or history of active liver disease
• ③ CPK \> 3x ULN
• Those participating in clinical trials of other drugs
• Other than the above who is deemed to be ineligible to participate in the trial by investigator

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atherosclerosis; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: July 13, 2018
• First Posted: July 24, 2018
• Study Start: October 17, 2018
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

KR (1)