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Simvastatin |
Zocor |
Clinical Trial: Ezetimibe (+) Simvastatin Vs. Atorvastatin Comparative Study
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 (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia 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 Vs. Atorvastatin in Patients with Primary Hypercholesterolemia.
Further Study Details:
Primary Outcomes: LDL-C lowering efficacy
Secondary Outcomes: safety
Expected Total Enrollment: 180
Secondary Outcomes: safety
Expected Total Enrollment: 180
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,
- LDL-C ≥130 mg/dL but ≤250 mg/dL and TG ≤350 mg/dL
- NCEP ATP III guideline
Exclusion Criteria:
1. Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00166504
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_070
Last Updated: September 13, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00166504
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20
Last Updated: September 13, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00166504
Health Authority: Korea: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20
Resources
- Simvastatin (Drug Digest)
- Simvastatin (Cleveland Clinic)
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