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IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
This study has been completed.
First Received: April 3, 2008   Last Updated: March 13, 2009   History of Changes
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:


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