12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

Phase 3

Completed

• Conditions: Hypercholesterolemia; Coronary Heart Disease; Atherosclerosis

• Registration Number: NCT00525824
• Lead Sponsor: AstraZeneca

Brief 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%

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-05
• Study First Submitted QC: 2007-09-05
• Study First Posted: 2007-09-06
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-03
• Results First Submitted QC: 2009-09-03
• Results First Posted: 2009-10-07
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1743

Inclusion Criteria

• 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

Exclusion Criteria

• Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
• Patients considered to be unstable by their physician after the following events:

a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100

Secondary Outcome Measures

Name	Time	Method
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in TG = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in TC = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment	Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)	Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value\*100
Percent Change in LDL-C After 6 Weeks Monotherapy	Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)	Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value\*100

Trial Locations

Locations (1)

Research Site; 🇻🇪 Brentwood, Venezuela