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

Hypercholesterolemia Clinical Trial

— SOLAR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654173
• Other study ID #: 4522US/0003
• Secondary ID: D3560L00023
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: March 13, 2009
• Start date: June 2002
• Est. completion date: September 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4444
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Simvastatin

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin		6 & 12 weeks
Secondary	Safety: adverse events & abnormal laboratory markers		6 & 12 weeks