Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: simvastatin (+) ezetimibe (Drug); atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6
in diabetics or metabolic syndrome patients in Korea.
Clinical Details
Official title: A Multicenter, Randomized, Open-Label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: LDL-C lowering efficacy
Secondary outcome: Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of hypercholesterolemia
- Drug naive or statin treated but inadequately controlled patients against NCEP ATP III
guideline goal
Exclusion Criteria:
- Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: March 7, 2008
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