Not Signed In -
Ezetimibe |
Zetia |
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
|
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
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
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
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