To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With High Cholesterol. - Article
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
|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.
Secondary Outcomes: Change in other lipid variables
Expected Total Enrollment: 990
Study start: November 2005
- Patient with LDL-C of 130 through 190 mg/dL and Triglycerides </= 500 mg/dL; Patient willing to be on a low-cholesterol diet
- 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
Medical Monitor, Study Director, Merck
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