Ezetrol Post-Marketing Study

NCT ID: NCT00753883

Last Updated: 2008-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31

Brief Summary

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

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

simvastatin 20 mg/qd for 8 weeks, and then add on ezetrol 10mg (if ldl-c . 160mg/dl) for another 8 weeks.

Group Type: ACTIVE_COMPARATOR

simvastatin

Intervention Type: DRUG

simvastatin 20 mg/QD for 6 Weeks.

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg/QD for 8 weeks.

2

ezetrol 10 mg/qd for 8 weeks, and then add on simvastatin 20 mg qd (if ldl-c . 160mg/dl) for another 8 weeks

Group Type: ACTIVE_COMPARATOR

simvastatin

Intervention Type: DRUG

simvastatin 20 mg/QD for 6 Weeks.

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg/QD for 8 weeks.

Interventions

simvastatin

simvastatin 20 mg/QD for 6 Weeks.

Intervention Type: DRUG

Ezetimibe

Ezetimibe 10 mg/QD for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

MK0733; Zocor®; Ezetrol; Zetia; MK0653

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck & Co., Inc.

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0653-154

Identifier Type: -

Identifier Source: secondary_id

2008_024

Identifier Type: -

Identifier Source: org_study_id