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Ezetrol Post-Marketing Study

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00753883
Collaborator
(none)
40
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2006
Actual Primary Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

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

Drug: simvastatin
simvastatin 20 mg/QD for 6 Weeks.
Other Names:
  • MK0733
  • Zocor®

    • Drug: Ezetimibe
    Ezetimibe 10 mg/QD for 8 weeks.
    Other Names:
  • Ezetrol
  • Zetia
  • MK0653

    		•
    Active Comparator: 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

    Drug: simvastatin
    simvastatin 20 mg/QD for 6 Weeks.
    Other Names:
  • MK0733
  • Zocor®

    • Drug: Ezetimibe
    Ezetimibe 10 mg/QD for 8 weeks.
    Other Names:
  • Ezetrol
  • Zetia
  • MK0653

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The change in lipid profiles after study drug treatment. [After 16 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00753883
    Other Study ID Numbers:
    • 2008_024
    • MK0653-154
    First Posted:
    Sep 17, 2008
    Last Update Posted:
    Sep 17, 2008
    Last Verified:
    Sep 1, 2008
    Additional relevant MeSH terms:
    Hyperlipidemias
    Simvastatin
    Ezetimibe

    Study Results

    No Results Posted as of Sep 17, 2008