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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00525824

Purpose

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%

Condition	Intervention	Phase
Hypercholesterolemia Coronary Heart Disease Atherosclerosis	Drug: Rosuvastatin (Crestor) Drug: Ezetimibe Drug: Simvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Atherosclerosis Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100

Secondary Outcome Measures:

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
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 [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
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 [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
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 [ Time Frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100
Percent Change in LDL-C After 6 Weeks Monotherapy [ Time Frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward) ] [ Designated as safety issue: No ]
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100

Enrollment:	1743
Study Start Date:	August 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

10mg and 20 mg

10 mg

40mg and 80 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525824

Locations

United States, Tennessee
Research Site
Brentwood, Tennessee, United States
Argentina
Research Site
Buenos Aires, Argentina
Brazil
Research Site
Sao Paulo, SP, Brazil
Chile
Research Site
Santiago, Chile
Colombia
Research Site
Brentwood, Colombia
Lithuania
Research Site
Brentwood, Lithuania
Netherlands
Research Site
Zwinderen, Netherlands
Peru
Research Site
Lima, San Isidro Lima, Peru
Venezuela
Research Site
Brentwood, Venezuela

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Christie M Ballantyne, MD FACP FACC	Centre for Cardiovascular Disease Prevention
Study Chair:	Margareta Grind, MD PhD FFPM	Medicine and Sciences AstraZeneca

More Information

No publications provided

Responsible Party:	Michael Cressman - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00525824 History of Changes
Other Study ID Numbers:	D356FC00003
Study First Received:	September 5, 2007
Results First Received:	September 3, 2009
Last Updated:	May 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Hypercholesterolaemia
Coronary Heart Disease (CHD)
Atherosclerosis

Additional relevant MeSH terms:

Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Simvastatin
Rosuvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012