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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- 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
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