NCT00092599CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 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
- 410
- Primary Endpoint
- Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Study Overview
Brief Summary
This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an 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 (Participant, Investigator)
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 who do not meet specific cholesterol levels as required by the study
Outcomes
Primary Outcomes
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Secondary Outcomes
- Safety and tolerability.
Investigators
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