Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR) - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654173

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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
1: Experimental Rosuvastatin	Drug: Rosuvastatin
2: Active Comparator Simvastatin	Drug: Simvastatin
3: Active Comparator Atorvastatin	Drug: Atorvastatin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654173

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Alex Gold, MD	AstraZeneca
Study Director:	Russell Esterline	AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	4522US/0003, D3560L00023
Study First Received:	March 26, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00654173 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor

Atorvastatin
Lipitor
Zocor
simvastatin

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010