NIPH Clinical Trials Search

UMIN ID: UMIN000001472

Registered date:01/11/2008

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedIHD subjects who are taking rosvastatin 2.5mg or atorvastatin 10mg more than 3 months and whose LDL-C is > 100mg/dl.
Date of first enrollment2008/10/01
Target sample size200
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Combination therapy wiht ezetimibe 10mg Increase in dose for both statins.


Primary Outcometotal cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, cholesterol absorption marker, cholesterol synthesis marker, glucose metabolic marker, inflammation marker, other laboratory findings.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1)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


public contact
Name Kazuaki Uchino
Address Japan
Affiliation Department of Medicine and Cardio-renal Medicine Department of Medicine and Cardio-renal Medicine
scientific contact
Name Noriaki Iwahashi
Address Urafune, Minami, Yokohama Japan
Telephone 045-261-5656
Affiliation Yokohama City University Center Hospital Department of Cardiology