At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,089 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice
In Brief
An observational study for Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH). Completed, enrolled 2,089 participants.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedFeb 2010
Primary CompletionApr 2010
TodayJul 2026
First PostedFeb 18, 2010
Enrollment StartJul 1, 2005
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.4 years ago