Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
SOLAR
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.
2 other identifiers
interventional
4,444
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedMarch 16, 2009
March 1, 2009
March 26, 2008
March 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
6 weeks
Secondary Outcomes (2)
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
Study Arms (3)
1
EXPERIMENTALRosuvastatin
2
ACTIVE COMPARATORSimvastatin
3
ACTIVE COMPARATORAtorvastatin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Gold, MD
AstraZeneca
- STUDY DIRECTOR
Russell Esterline
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2008
First Posted
April 7, 2008
Study Start
June 1, 2002
Study Completion
September 1, 2004
Last Updated
March 16, 2009
Record last verified: 2009-03