IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin - Full Text View

Purpose

The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia

Condition	Intervention	Phase
Fredrickson Type IIa & Type IIb Dyslipidaemia	Drug: Rosuvastatin Drug: Simvastatin	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

ChemIDplus related topics:

Rosuvastatin Rosuvastatin calcium Simvastatin Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Development of Proteinuria [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Renal effects of rosuvastatin and simvastatin [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
Low density lipoproteins cholesterol levels [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
Safety: adverse events & abnormal laboratory markers [ Time Frame: 2 weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	442
Study Start Date:	September 2002
Study Completion Date:	July 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rosuvastatin	Drug: Rosuvastatin
2: Active Comparator Simvastatin	Drug: Simvastatin

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 creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654446

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Evan Stein	Metabolic & Athersclerotic research centre, Cincinatti, USA

Study Director:	Russell Esterline	AstraZeneca

More Information

Responsible Party:	AstraZeneca ( Michael Cressman - Medical Science Director )
Study ID Numbers:	4522IL/0099
First Received:	April 3, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00654446
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Israel: Israeli Health Ministry Pharmaceutical Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; South Africa: Medicines Control Council

Keywords provided by AstraZeneca:

Cholesterol

low density lipoproteins

dyslipidaemia

Rosuvastatin

Crestor

Simvastatin

Zocor

Renal

kidney

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors

Hypercholesterolemia, autosomal dominant

Hyperlipidemias

Metabolic Diseases

Simvastatin

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 October 10, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654446