NCT00092638CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Added to Existing Atorvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 450
- Primary Endpoint
- Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.
Study Overview
Brief Summary
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.
Detailed Description
The duration of treatment is 10 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with elevated cholesterol and coronary heart disease
Exclusion Criteria
- •Patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements
Outcomes
Primary Outcomes
Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.
Secondary Outcomes
- Safety and tolerability.
Investigators
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