Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe (+) simvastatin (Drug); atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: LDL-C Lowering Efficacy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of hypercholesterolemia
- LDL-C >/= 130 mg/dL but =250 mg/dL and triglyceride (TG) = 350 mg/dL
- National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III
guideline
Exclusion Criteria:
- Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase)
inhibitors or Ezetimibe
Locations and Contacts
Additional Information
Starting date: October 2005
Last updated: January 14, 2015
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