NCT00092651CompletedPhase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 1,398
- Primary Endpoint
- Plasma LDL-C
Study Overview
Brief Summary
The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).
Detailed Description
The duration of treatment is 4 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •High cholesterol
Exclusion Criteria
- •Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
Outcomes
Primary Outcomes
Plasma LDL-C
Time Frame: From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.
Secondary Outcomes
- Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.(From baseline to study end point in TC, TG, HDL-C, ratios of direct LDL-C:HDL-C and TC:HDL-C, non-HDL-C, Apo B, Apo A-I, Apo A-II, Apo E, lipoprotein(a), C[1]reactive protein (CRP), and fibrinogen, after 12 weeks of treatment.)
Investigators
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