To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe (Drug); atorvastatin (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe
plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high
risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.
Clinical Details
Official title: A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 mg
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in LDL-C
Secondary outcome: Change in other lipid variables
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg.
Exclusion Criteria:
- Pregnant or lactating women or intending to become pregnant
- Patient with sensitivity or intolerance to ezetimibe or atorvastatin
- Patient with diabetes or coronary heart disease
Locations and Contacts
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: January 2006
Last updated: April 24, 2008
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