A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD

Status: Completed
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20

• Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.

• Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

Locations
United States
Tennessee
Research Site
Brentwood
Other Locations
Argentina
Research Site
Buenos Aires
Bolivarian Republic of Venezuela
Research Site
Brentwood
Brazil
Research Site
Sao Paulo
Chile
Research Site
Santiago
Colombia
Research Site
Brentwood
Lithuania
Research Site
Brentwood
Netherlands
Research Site
Zwinderen
Peru
Research Site
Lima
Time Frame
Start Date: August 2007
Completion Date: September 2008
Participants
Target number of participants: 1743
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov