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Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin

NCT04080310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2020-03-20

No results posted yet for this study

Summary

This study is a multicenter, randomized, open-label, parallel, phase IV trial.

The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.

Conditions

Interventions

DRUG

Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin

This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy. After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.

Sponsors & Collaborators

  • Yuhan Corporation

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-06-15
Completion
2019-09-17

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080310 on ClinicalTrials.gov