Ezetrol Post-Marketing Study
- Registration Number
- NCT00753883
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Men Or Women Older Than 20 And Younger Than 80 Years Of Age
- Willing To Follow An Ncep Therapeutic Lifestyle Changes (TLC) Or Similar Cholesterol-Lowering Diet For The Duration Of The Study
- Female Patients Receiving Hormone Therapy (Including Hormone Replacement Therapy, And Estrogen Antagonist/Agonist, Or Oral Contraceptives) If Maintained On A Stable Dose And Regimen For At Least 8 Weeks Prior To Visit 1 And If Willing To Continue The Same Regimen Throughout The Study
- Patient With Total Cholesterol Equal Or Greater Than 240 Mg/Dl Or Ldl-C Equal Or Greater Than 160 Mg/Dl For Primary (Heterozygous Familial And Non-Familial) Hypercholesterolemia And/Or Ldl-C Equal Or Greater Than 130 Mg/Dl For Secondary Hypercholesterolemia With Identifiable Risk Factors
- Patient Is Able To Discontinue Any Lipid Lowering Drugs For 6-8 Weeks Wash-Out Period (6 Week For Statin And 8 Week For Fibrate)
- Triglyceride (Tg) Concentrations Equal Or Less Than 400 Mg/Dl
- Liver Transaminases (Alt, Ast) Equal Or Less Than 1.5x Uln With No Active Liver Disease And Equal Or Less Than 1.5x Uln At Visit 2
Exclusion Criteria
- Women Who Are Pregnant Or Lactating
- History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major Psychiatric Illness Not Adequately Controlled And Stable On Pharmacotherapy
- Patients Who Have Been Treated With Any Other Investigational Drug Within 3 Months Of Visit 1
- Patients Previously Randomized To A Study With Ezetimibe
- Active Liver Disease Or Impaired Liver Function Tests (Alt, Ast > 1.5xuln)
- Impaired Renal Function ( Serum Creatinine Equal Or Greater Than 1.5 Mg/Dl Or Urine Protein Equal Or Greater Than 100 Mg/L) Or Nephritic Syndrome At Visit 1
- Unstable Angina
- Myocardial Infarction, Coronary Bypass Surgery Or Angioplasty Within The Previous Three Months Of Visit 1
- Uncontrolled Cardiac Arrhythmias
- Uncontrolled Hypertension (Treated Or Untreated) With Systolic Blood Pressure > 160 Mmhg Or Diastolic > 100 Mmhg At Visit 1
- Poorly Controlled Diabetes Mellitus Patient. (Hba1c>8.0%). If The Patient Treated With Md, No Any Dm Medication Will Be Change During The Study Period)
- Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoprotein, E.G. Hyperthyroidism (Tsh > 5.5 (Iu/Ml). However, Patients Who Are On A Stable Therapy Of Thyroid Replacement Therapy For At Least 6 Weeks Are Eligible For Enrollment
- Patients Hypersensitive To Hmg-Coa Reductase Inhibitors Or Ezetimibe
- Patient Who Is Unable To Give Informed Consent (The Patient With A Legal Representative To Sign The Informed Consent Is Eligible To Participate The Study.)
- Any Condition Or Situation Which, In The Opinion Of The Investigator, Might Pose A Risk To The Patient Or Confound The Results Of The Study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 simvastatin ezetrol 10 mg/qd for 8 weeks, and then add on simvastatin 20 mg qd (if ldl-c . 160mg/dl) for another 8 weeks 1 simvastatin simvastatin 20 mg/qd for 8 weeks, and then add on ezetrol 10mg (if ldl-c . 160mg/dl) for another 8 weeks. 1 Ezetimibe simvastatin 20 mg/qd for 8 weeks, and then add on ezetrol 10mg (if ldl-c . 160mg/dl) for another 8 weeks. 2 Ezetimibe ezetrol 10 mg/qd for 8 weeks, and then add on simvastatin 20 mg qd (if ldl-c . 160mg/dl) for another 8 weeks
- Primary Outcome Measures
Name Time Method The change in lipid profiles after study drug treatment. After 16 Weeks
- Secondary Outcome Measures
Name Time Method