Not Signed In -
Ezetimibe |
Zetia |
Clinical Trial: Ezetimibe (+) Simvastatin Vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients
This study is not yet open for patient recruitment.
Verified by Merck September 2005
|
Purpose
An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.
| Condition | Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: MK0653A; ezetimibe (+) simvastatin | Phase IV |
MedlinePlus related topics: Cholesterol
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Further Study Details:
Primary Outcomes: LDL-C lowering efficacy
Secondary Outcomes: Safety
Expected Total Enrollment: 190
Secondary Outcomes: Safety
Expected Total Enrollment: 190
Study start: October 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- clinical diagnosis of hypercholesterolemia
- drug naïve or statin treated but inadequately controlled patients against NCEP ATP III guideline goal
Exclusion Criteria:
- Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00157924
Korea, Republic of
MSD Korea Ltd., Seoul, 121-705, Korea, Republic of
Paul Jang, Dr. 822-8383-0024
Study chairs or principal investigators
Medical Monitor, Study Director, Merck
More Information
Study ID Numbers: 2005_064
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00157924
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00157924
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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