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Vytorin Reexamination Study (0653A-174)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070966
First Posted: February 18, 2010
Last Update Posted: November 2, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Condition
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation [ Time Frame: Up to 14 days after the treatment discontinuation ]
    Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.

  • Mean Percent Change From Baseline to Treatment in Lipid Parameters [ Time Frame: Baseline and up to 5 years ]
    The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.


Enrollment: 2089
Study Start Date: July 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)
VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)
VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)
VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin
Criteria

Inclusion Criteria:

  • Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01070966     History of Changes
Other Study ID Numbers: 0653A-174
2010_010
First Submitted: February 17, 2010
First Posted: February 18, 2010
Results First Submitted: April 14, 2011
Results First Posted: May 10, 2011
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Atherosclerosis

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors