Hypercholesterolemia
Conditions
Brief 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
Interventions
DRUGezetimibe
ezetimibe 10 mg/day for a six week course of treatment.
DRUGstatins
patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 6 weeks |
Outcome results
None listed