Not Signed In -
Ezetimibe |
Zetia |
Clinical Trial: To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 Mg.
This study is not yet open for patient recruitment.
Verified by Merck January 2006
|
Purpose
To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.
| Condition | Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: MK0653, ezetimibe / Duration of Treatment: 6 weeks Drug: Comparator: atorvastatin / Duration of Treatment: 6 weeks | Phase III |
MedlinePlus related topics: Cholesterol
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multictr., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg.
Further study details as provided by Merck:
Primary Outcomes: Change in LDL-C
Secondary Outcomes: Change in other lipid variables
Expected Total Enrollment: 554
Secondary Outcomes: Change in other lipid variables
Expected Total Enrollment: 554
Study start: January 2006
Eligibility
Ages Eligible for Study: 18 Years - 79 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg.
Exclusion Criteria:
- Pregnant or lactating women or intending to become pregnant
- Patient with sensitivity or intolerance to ezetimibe or atorvastatin
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00276484
Call for Site Information 1-888-577-8839
Study chairs or principal investigators
Medical Monitor, Study Director, Merck
More Information
Study ID Numbers: 2005_105
Last Updated: January 12, 2006
Record first received: January 11, 2006
ClinicalTrials.gov Identifier: NCT00276484
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
Last Updated: January 12, 2006
Record first received: January 11, 2006
ClinicalTrials.gov Identifier: NCT00276484
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
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