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Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909389
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : October 4, 2011
Last Update Posted : June 22, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study aims to establish the safety, tolerability, and efficacy of Vytorin (R) (Ezetimibe + Simvastatin) (SCH 465981) on a select population of Filipinos with hypercholesterolemia.

Condition or disease Intervention/treatment
Hypercholesterolemia Drug: Vytorin (R) (Ezetimibe + Simvastatin)

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Study Type : Observational
Actual Enrollment : 4748 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients
Study Start Date : November 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Filipino Patients with Hypercholesterolemia Drug: Vytorin (R) (Ezetimibe + Simvastatin)
Vytorin (R) (Ezetimibe + Simvastatin) 1 tablet once daily to be taken by mouth in the evening for 28 days
Other Name: SCH 465981

Primary Outcome Measures :
  1. Number of Participants Who Had an Adverse Event (AE). [ Time Frame: Throughout study up to Day 29 (Final Visit) ]

    The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia.

    All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years old and above seen in the outpatient clinic who were diagnosed to have hypercholesterolemia. Patients with primary (heterozygous familial and non - familial) hypercholesterolemia or homozygous familial hypercholesterolemia were also included.

Inclusion Criteria:

  • Outpatient men or women, age 18 years and above
  • Patients with primary (heterozygous familial and non-familial) hypercholesterolemia

Exclusion Criteria:

  • Known hypersensitivity to Ezetimibe and Simvastatin
  • Moderate to severe hepatic insufficiency
  • Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal
  • Pregnancy or lactation
  • Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00909389    
Other Study ID Numbers: P05647
First Posted: May 28, 2009    Key Record Dates
Results First Posted: October 4, 2011
Last Update Posted: June 22, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors