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Clinical Trials/NCT00092716
NCT00092716CompletedPhase 3

A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia

Organon and Co0 sites655 target enrollmentStarted: May 1, 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
655
Primary Endpoint
To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Elevated cholesterol levels

Exclusion Criteria

  • •Liver disease
  • •Unstable medical conditions

Outcomes

Primary Outcomes

To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.

Secondary Outcomes

  • Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
  • Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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