Ezetrol Post-Marketing Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Simvastatin

Criteria

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