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

2019-09-12 02:34:42 | BioPortfolio

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.

Description

The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.

After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.

The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.

Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.

The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.

Study Design

Conditions

Cardiovascular Diseases

Intervention

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

Location

Seoul National University Bundang Hospital
Seongnam-si
Gyeonggi-do
Korea, Republic of
06511

Status

Active, not recruiting

Source

Seoul National University Bundang Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-12T02:34:42-0400

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A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

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