Hyperlipidemia
Conditions
Brief summary
To compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.
Interventions
DRUGsimvastatin
simvastatin 20 mg/QD for 6 Weeks.
DRUGEzetimibe
Ezetimibe 10 mg/QD for 8 weeks.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in lipid profiles after study drug treatment. | After 16 Weeks |
Outcome results
None listed