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To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With High Cholesterol. - Article


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Cholesterol

 



Clinical Trial: To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With High Cholesterol.

This study is not yet open for patient recruitment.
Verified by Merck December 2005

Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00271817

Purpose

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
Condition Intervention Phase
Hypercholesterolemia
 Drug: MK0653a tablet / Duration of Treatment - 1 Year
 Drug: Comparator: niacin extended release tablet / Duration of Treatment - 1 Year
Phase III

MedlinePlus related topics:  Cholesterol

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia.

Further study details as provided by Merck:
Primary Outcomes: Change in non-HDL-C
Secondary Outcomes: Change in other lipid variables
Expected Total Enrollment:  990

Study start: November 2005

Eligibility

Ages Eligible for Study:  18 Years   -   79 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patient with LDL-C of 130 through 190 mg/dL and Triglycerides </= 500 mg/dL; Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

  • Pregnant of lactating women or intending to become pregnant; Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet; Patient with sensitivity or intolerance to niacin, any component of niacin extended release of aspirin, Patient for whom discontinuation of existing lipid-lowering therapy poses an unacceptable risk

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00271817

Toll Free Number      1-888-577-8839 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Merck   

More Information

Study ID Numbers:  2005_091
Last Updated:  January 3, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00271817
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10

Resources



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Page Updated: June 20, 2006
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