Vytorin Reexamination Study (0653A-174)

February 7, 2022 updated by: Organon and Co

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin

Description

Inclusion Criteria:

  • Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 14 days after the treatment discontinuation
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.
Baseline and up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653A-174
  • 2010_010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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