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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654173     History of Changes
Other Study ID Numbers: 4522US/0003, D3560L00023
Study First Received: March 26, 2008
Last Updated: March 13, 2009
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:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014