High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in ASCVD Patients

NCT03494270 | Completed Phase 4

• 1 other identifier: YMC033
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of high-intensity rosuvastatin and moderate-intensity rosuvastatin/ezetimibe in ASCVD patients.

Conditions

ASCVD

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 12

Secondary Outcomes (9)

• Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), Non-HDL cholesterol, Apolipoprotein A1, and Apolipoprotein B

  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 fasting plasma glucose (FPG)

  Baseline, Week 12, Week 24

• Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)

  Baseline, Week 12, Week 24

• Proportion of subjects achieving LDL-C < 70mg/dL

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

You may qualify if:

• Aged 19 to 75 years
• Patients diagnosed with ASCVD (coronary artery disease)
• acute coronary syndrome
• history of myocardial infarction (MI)
• stable or unstable angina
• history of coronary revascularization
• stroke or transient ischemic attack (TIA)
• peripheral arterial disease, history of peripheral arterial revascularization
• Taking a stable dose of a statin or a lipid-lowering agent of ezetimibe over 4 weeks before randomization
• Written informed consent

You may not qualify if:

• Administration of other lipid lowering agents than statin or ezetimibe within 3 months prior to screening visit
• Fasting triglyceride ≥ 400 mg/dL
• 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
• Administration of other investigational products within 30 days prior to screening visit
• 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)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Related Publications (1)

• Choi H, Kang SH, Jeong SW, Yoon CH, Youn TJ, Song WH, Jeon DW, Lim SW, Lee JH, Cho SW, Chae IH, Kim CH. Lipid-Lowering Efficacy of Combination Therapy With Moderate-Intensity Statin and Ezetimibe Versus High-Intensity Statin Monotherapy: A Randomized, Open-Label, Non-Inferiority Trial From Korea. J Lipid Atheroscler. 2023 Sep;12(3):277-289. doi: 10.12997/jla.2023.12.3.277. Epub 2023 Aug 3.

  PMID: 37800112 DERIVED

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: April 2, 2018
• First Posted: April 11, 2018
• Study Start: March 18, 2018
• Primary Completion: September 26, 2019
• Study Completion: September 26, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

KR (1)