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Clinical Trials/NCT00654173
NCT00654173CompletedPhase 3

A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.

AstraZeneca0 sites4,444 target enrollmentStarted: June 2002Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
4,444
Primary Endpoint
Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.

Study Overview

Brief Summary

The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • Member of managed care plan for hypercholesterolemia
  • Fasting blood lipid levels as defined by the protocol
  • Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease

Exclusion Criteria

  • The use of lipid lowering drugs or dietary supplements after Visit
  • Active arterial disease eg Unstable angina, or recent arterial surgery
  • Blood lipid levels above the limits defined in the protocol.
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Arms & Interventions

1

Experimental

Rosuvastatin

Intervention: Rosuvastatin (Drug)

2

Active Comparator

Simvastatin

Intervention: Simvastatin (Drug)

3

Active Comparator

Atorvastatin

Intervention: Atorvastatin (Drug)

Outcomes

Primary Outcomes

Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.

Time Frame: 6 weeks

Secondary Outcomes

  • Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin(6 & 12 weeks)
  • Safety: adverse events & abnormal laboratory markers(6 & 12 weeks)

Investigators

Sponsor Class
Industry

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