Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin

UMIN ID: UMIN000001472

Registered date:01/11/2008

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: IHD subjects who are taking rosvastatin 2.5mg or atorvastatin 10mg more than 3 months and whose LDL-C is > 100mg/dl.
• Date of first enrollment: 2008/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Combination therapy wiht ezetimibe 10mg
Increase in dose for both statins.

Outcome(s)

• Primary Outcome: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, cholesterol absorption marker, cholesterol synthesis marker, glucose metabolic marker, inflammation marker, other laboratory findings.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Subjects with hypersentivity for ezetimibe or staitns. 2)triglyceride>500mg/dl 3)liver dysfunction (AST>twice as much as the upperlimit of the facilities. 4)kidney dysfunction (serum Cr>2.0mg/dl) 5)secondary hyperlipidemia or drug induced hyperlipidemia 6)unstabel angina, myocardial infarction, coronary bypass surgery, brain infarction within 3 months. 7)pregnancy, lactation, possible pregnancy 8)According to the attending physician`s judgements

Related Information

• Primary Sponsor: Yokohama City University Graduate School of Medicine, Department of Medicine and Cardio-renal Medicine
• Source(s) of Monetary Support: Yokohama City University Center Hospital Department of Cardiology