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

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia primary carnitine deficiency

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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:	April 2004

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

No publications provided

Responsible Party:	AstraZeneca ( Michael Cressman - Medical Science Director )
Study ID Numbers:	4522IL/0099
Study First Received:	April 3, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00654446 History of Changes
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

Additional relevant MeSH terms:

Lipid Metabolism, Inborn Errors
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Hyperlipoproteinemia Type II
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Metabolism, Inborn Errors
Rosuvastatin
Genetic Diseases, Inborn
Therapeutic Uses
Dyslipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010