Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00653445

Purpose

The purpose of this study is to compare 6 weeks of treatment with rosuvastatin alone compared with 6 weeks of treatment of rosuvastatin combined with ezetimibe in achieving low density lipoprotein level goals.

Condition	Intervention	Phase
Hypercholesterolemia Coronary Heart Disease Atherosclerosis	Drug: Rosuvastatin Drug: Ezetimibe	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A 6wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel Group Study to Compare the Safety & Efficacy of Rosuvastatin 40mg in Comb.With Ezetimibe 10mg in Subjects With Hypercholesterolaemia & CHD or Atherosclerosis or a CHD Risk Equiv. (10 yr Risk Score >20%).

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting low-density lipoprotein cholesterol (LDL-C) levels at baseline and Week 6

Secondary Outcome Measures:

To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by measuring fasting blood lipid levels levels at baseline and Week 6
Safety: by measuring adverse events & abnormal laboratory markers to compare safety & tolerability of rosuvastatin alone with rosuvastatin combined with ezetimibe

Study Start Date:	June 2004
Study Completion Date:	June 2005

Arms	Assigned Interventions
1: Experimental Rosuvastatin 40mg/Ezetimibe 10mg combination therapy	Drug: Rosuvastatin 40mg Drug: Ezetimibe 10mg
2: Experimental Rosuvastatin 40 mg	Drug: Rosuvastatin 40mg

Eligibility

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

Criteria

Inclusion Criteria:

A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
Discontinuation of all lipid lowering therapy at Visit 1.

Exclusion Criteria:

History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
Severe congestive cardiac failure (as defined by the protocol - Appendix I).
Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1)..

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653445

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Christine Ballantyne, MD

Centre for prevention of cardiovascular disease, Texas, USA

More Information

No publications provided

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	D3569C00006
Study First Received:	April 2, 2008
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00653445 History of Changes
Health Authority:	United States: Food and Drug Administration; Switzerland: Swissmedic; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Department of Health

Keywords provided by AstraZeneca:

Low density lipoproteins
Hypercholesterolemia
Coronary Heart Disease

Rosuvastatin
Crestor
Ezetimibe

Study placed in the following topic categories:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Myocardial Ischemia
Vascular Diseases
Ezetimibe
Anticholesteremic Agents

Arteriosclerosis
Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Disease
Rosuvastatin
Metabolic Disorder
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Metabolic Diseases
Heart Diseases
Hyperlipidemias
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Myocardial Ischemia
Vascular Diseases
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Rosuvastatin
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009