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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Rosuvastatin Rosuvastatin calcium Ezetimibe

U.S. FDA Resources

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%).

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:	September 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

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

Responsible Party:	AstraZeneca ( Elisabeth Björk )
Study ID Numbers:	D3569C00006
Study First Received:	April 2, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00653445
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:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Ezetimibe
Arteriosclerosis

Ischemia
Coronary Disease
Rosuvastatin
Metabolic disorder
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009