Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 1,140
- Primary Endpoint
- 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.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
group 1
group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months.
Intervention: ezetimibe (Drug)
group 1
group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months.
Intervention: statins (Drug)
Group 2
Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase.
Intervention: statins (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 6 weeks
Secondary Outcomes
No secondary outcomes reported