Clinical trial NCT00753883: Ezetrol Post-Marketing Study
Official title: A Randomized, Open-Labeled, Parallel Group Comparison Study to Evaluate the Efficacy, Safety of Ezetimibe Alone Versus Statin in the Treatment of Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The change in lipid profiles after study drug treatment.
timeFrame: After 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: