Ezetrol Post-Marketing Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753883

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2014