NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001718

Registered date:23/02/2009

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.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHypercholesterolemia
Date of first enrollment2008/05/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
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 Outcome1. 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 OutcomeChanges of RLP-cholesterol, HDL-C, triglyceride, insulin, plasma glucose, HbA1c, and hs-CRP.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaSevere liver or renal dysfunction. The patient using fibrate or insulin. Secondary hypercholesterolemia. Pregnant women.

Related Information

Contact

public contact
Name Hiroaki Ueno
Address 5200, kihara, Kiyotake, Miyazaki, Japan Japan
Telephone 0985-85-2965
E-mail intron@med.miyazaki-u.ac.jp
Affiliation Miyazaki Medical College, University of Miyazaki Neurology, Respirology, Endocrinology and Metabolism
scientific contact
Name Masamitsu Nakazato
Address 5200, kihara, Kiyotake, Miyazaki, Japan Japan
Telephone 0985-85-2965
E-mail
Affiliation Miyazaki Medical College, University of Miyazaki Neurology, Respirology, Endocrinology and Metabolism