Vytorin Reexamination Study (0653A-174)

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)<br>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)<br>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)<br>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)<br>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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis