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Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654173
First received: March 26, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes

March 26, 2008
March 13, 2009
June 2002
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00654173 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 & 12 weeks ]
Same as current
Not Provided
Not Provided
 
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (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.

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Drug: Simvastatin
    Other Name: Zocor
  • Drug: Atorvastatin
    Other Name: Lipitor
  • Experimental: 1
    Rosuvastatin
    Intervention: Drug: Rosuvastatin
  • Active Comparator: 2
    Simvastatin
    Intervention: Drug: Simvastatin
  • Active Comparator: 3
    Atorvastatin
    Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4444
September 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00654173
4522US/0003, D3560L00023
No
Elisabeth Björk, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Alex Gold, MD AstraZeneca
Study Director: Russell Esterline AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP