Back to resultsComparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR) (SOLAR)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Simvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, Zocor, simvastatin
Eligibility Criteria
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 1.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Rosuvastatin
Simvastatin
Atorvastatin
Outcomes
Primary Outcome Measures
Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
Secondary Outcome Measures
Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin
Safety: adverse events & abnormal laboratory markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654173
Brief Title
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
Acronym
SOLAR
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, Zocor, simvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Simvastatin
Arm Title
3
Arm Type
Active Comparator
Arm Description
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin
Time Frame
6 & 12 weeks
Title
Safety: adverse events & abnormal laboratory markers
Time Frame
6 & 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 1.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Gold, MD
Organizational Affiliation
AstraZeneca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Esterline
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
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