Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption.

UMIN ID: UMIN000001718

Registered date:23/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia
• Date of first enrollment: 2008/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Twelve weeks Ezetimibe administration to the patients with hypercholesterolemia without statins.
Twelve weeks Ezetimibe administration to the patients with hypercholesterolemia taking statins.

Outcome(s)

• Primary Outcome: 1. Association between the cholesterol asynthesis/absorption markers before Ezetimibe administration and coronary risk factors or arteriosclerotic diseases. 2. Amount or rate of changes in LDL-C after Ezetimibe administration. 3. Correlation between the amount or rate of changes in LDL-C after Ezetimibe administration and the cholesterol synthesis/absorption markers.
• Secondary Outcome: Changes of RLP-cholesterol, HDL-C, triglyceride, insulin, plasma glucose, HbA1c, and hs-CRP.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Severe liver or renal dysfunction. The patient using fibrate or insulin. Secondary hypercholesterolemia. Pregnant women.

Related Information

• Primary Sponsor: Neurology, Respirology, Endocrinology and Metabolism, Miyazaki Medical College, University of Miyazaki
• Source(s) of Monetary Support: Ministry of education, culture, sports, science & technology