Clinical trial NCT00525824: 12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Coronary Heart Disease
Atherosclerosis
Keywords: Hypercholesterolaemia
Coronary Heart Disease (CHD)
Atherosclerosis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-06
Enrollment: 1743
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Secondary outcomes:
measure: Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
timeFrame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
measure: Percent Change in LDL-C After 6 Weeks Monotherapy
timeFrame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: Research Site
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Santiago
country: Chile
facility: Research Site
city: Brentwood
country: Colombia
facility: Research Site
city: Brentwood
country: Lithuania
facility: Research Site
city: Zwinderen
country: Netherlands
facility: Research Site
city: Lima
country: Peru
facility: Research Site
state: San Isidro Lima
city: Brentwood
country: Venezuela
facility: Research Site
Study officials:
affiliation: Centre for Cardiovascular Disease Prevention
name: Christie M Ballantyne, MD FACP FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicine and Sciences AstraZeneca
name: Margareta Grind, MD PhD FFPM
role: STUDY_CHAIR
References: