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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00654173
First Posted: April 7, 2008
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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

Condition Intervention Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Simvastatin Drug: Atorvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4444
Study Start Date: June 2002
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Simvastatin
Drug: Simvastatin
Other Name: Zocor
Active Comparator: 3
Atorvastatin
Drug: Atorvastatin
Other Name: Lipitor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654173


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Alex Gold, MD AstraZeneca
Study Director: Russell Esterline AstraZeneca
  More Information

Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654173     History of Changes
Other Study ID Numbers: 4522US/0003
D3560L00023
First Submitted: March 26, 2008
First Posted: April 7, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Atorvastatin
Lipitor
Zocor
simvastatin

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors