48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654602

Purpose

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Condition	Intervention	Phase
Dyslipidaemia	Drug: Rosuvastatin Behavioral: Maintenance of specific diet	Phase III

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Reduction in low density lipoprotein cholesterol levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Reduction in low density lipoprotein cholesterol levels [ Time Frame: 24 & 48 weeks ]
Safety: adverse events & abnormal laboratory markers [ Time Frame: 4 weekly until week 12 then 12 weekly thereafter. ]
Maintenance of lowered low density lipoprotein cholesterol level [ Time Frame: Between week 12-48 ]

Estimated Enrollment:	1500
Study Start Date:	February 2002
Study Completion Date:	February 2005
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Fasting low density lipoprotein level as defined by the protocol.
Fasting triglyceride level as defined by the protocol.

Exclusion Criteria:

The use of lipid lowering drugs or dietary supplements after Visit 1.
Active arterial disease eg Unstable angina, or recent arterial surgery.
Blood lipid levels above the limits defined in the protocol.
Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654602

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Dr. Evan Stein	Metabolic & Athersclerotic research centre, USA
Study Director:	Russell Esterline	AstraZeneca

More Information

Study ID Numbers:	4522Il/0091, D3560C00091
Study First Received:	April 3, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00654602
Health Authority:	Australia: National Health and Medical Research Council; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; South Africa: Medicines Control Council

Keywords provided by AstraZeneca:

cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hypercholesterolemia, autosomal dominant
Hyperlipidemias
Metabolic Diseases
Hyperlipoproteinemia Type II
Metabolism, Inborn Errors
Rosuvastatin

Genetic Diseases, Inborn
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009