Ezetrol Post-Marketing Study

NCT00753883 | Completed Phase 4

• 2 other identifiers: 2008_024MK0653-154
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• The change in lipid profiles after study drug treatment.

  After 16 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: simvastatin; Drug: Ezetimibe

2

ACTIVE COMPARATOR

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; Drug: Ezetimibe

Interventions

simvastatin DRUG

simvastatin 20 mg/QD for 6 Weeks.

Also known as: MK0733, Zocor®

1; 2

Ezetimibe DRUG

Ezetimibe 10 mg/QD for 8 weeks.

Also known as: Ezetrol, Zetia, MK0653

1; 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Simvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: July 1, 2006
• Primary Completion: May 1, 2008
• Last Updated: September 17, 2008

Record last verified: 2008-09