At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 203 enrolled
Drug / intervention
ezetimibe (+) simvastatin +1 moredrug
Likely dose
Ezetimibe/simvastatin 10/20 mg or atorvastatin 10 mg orallyAI-extracted
Key inclusion· 4
- ✓Clinical diagnosis of hypercholesterolemia
- ✓LDL-C ≥130 mg/dL but ≤250 mg/dL
- ✓Triglyceride level ≤350 mg/dL
- ✓Meets NCEP ATP III guidelines
Key exclusion· 2
- ✕Hypersensitivity to HMG-CoA reductase inhibitors
- ✕Hypersensitivity to ezetimibe
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
In Brief
A Phase 4 clinical trial evaluating ezetimibe (+) simvastatin and atorvastatin for Hypercholesterolemia. Completed, enrolled 203 participants.
Detailed Summary
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2005
Enrollment StartOct 2005
Primary CompletionOct 2007
TodayJul 2026
First PostedSep 14, 2005
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.8 years ago
Interventions
ezetimibe (+) simvastatindrug
simvastatin/ezetimibe 10/20 mg
atorvastatindrug
atorvastatin 10 mg