To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 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); Comparator: atorvastatin (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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.
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 Patients. at High Risk for CHD Not Adequately Controlled on Atorvastatin 40 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 >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
Locations and Contacts
Additional Information
Starting date: January 2006
Ending date: February 2008
Last updated: January 15, 2008
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