NCT00092690CompletedPhase 3
A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Hypercholesterolemia
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 1,902
- Primary Endpoint
- Plasma LDL-C averaged across all doses after 6 weeks
Study Overview
Brief Summary
This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.
Detailed Description
The duration of treatment is 6 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elevated cholesterol
Exclusion Criteria
- •Unstable medical conditions or significant heart problems within 3 months prior to first study visit.
Outcomes
Primary Outcomes
Plasma LDL-C averaged across all doses after 6 weeks
Secondary Outcomes
- Plasma LDL-C for each dose; plasma HDL-C averaged across all doses
Investigators
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