Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia
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); statins (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To compare the percent (%) change in plasma LDL-C concentration, after a six week course of
treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of
the existing statin dose
Clinical Details
Official title: Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary measure of efficacy will be the percent change in plasma LDL-cholesterol between baseline and the final study assessment after six weeks of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients With A Diagnosis Of Primary Hypercholesterolemia And
- Who Are Defined As Being "High Risk" (10-Year Risk Of Coronary Artery Disease > 20 %
Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis
Disease)
- And Have Not Reached Their Recommended Ldl-C Target Levels Of 2. 5 Mmol/L While On A
Statin Alone
Exclusion Criteria:
-
Locations and Contacts
Additional Information
Starting date: May 2005
Last updated: May 13, 2008
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