Efficacy of Ezetimibe for the patients with Non-alcoholic fatty liver disease (NAFLD)

UMIN ID: UMIN000001071

Registered date:30/06/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-alcoholic fatty liver disease
• Date of first enrollment: 2008/02/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The research dietitian instructed all subjects to reduce their caloric intake by 300 kcal per day. The subjects were randomly assigned to receive one of the regimens; in Group A, the patients will receive Ezetimibe at a dose of 10mg per day for 6 months.
The research dietitian instructed all subjects to reduce their caloric intake by 300 kcal per day. The subjects were randomly assigned to receive one of the regimens; in Group B, the patients will receive no drug for 6 months.

Outcome(s)

• Primary Outcome: changes of AST, ALT, Total cholesterol, and LDL-cholesterol at month 6 after the start of therapy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. past history of hypersensitivity to Ezetimibe 2. clinical sighs of severe liver injury such as acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis in Child B or C, hepatocellular carcinoma, and jaundice in combination with Statin. 3. women who are or possibly pregnant 4. past history of atherosclerotic disease(myocardial infarction , angina pectoris, cerebral stroke, and so on). 5. secondry hyperlipidemia or drug induced hyperlipidemia

Related Information

• Primary Sponsor: Osaka City University Graduate School of Medicine
• Source(s) of Monetary Support: None