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Ezetrol Post-Marketing Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00753883
First received: September 16, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hyperlipidemia
 Drug: simvastatin
Drug: Ezetimibe
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • The change in lipid profiles after study drug treatment. [ Time Frame: After 16 Weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753883

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00753883     History of Changes
Other Study ID Numbers: 2008_024, MK0653-154
Study First Received: September 16, 2008
Last Updated: September 16, 2008
Health Authority: Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013