Vytorin Reexamination Study (0653A-174)

Organon

Status: Completed

Conditions: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Study type: Observational

Funder types: Industry

Identifiers

NCT01070966

0653A-174

2010_010

Details and patient eligibility

About

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.

Enrollment: 2,089 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

2,089 participants in 4 patient groups

VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)

Description:

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)

Description:

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)

Description:

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)

Description:

Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)