IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654446
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : March 16, 2009
Information provided by:

April 3, 2008
April 8, 2008
March 16, 2009
September 2002
Not Provided
Development of Proteinuria [ Time Frame: 2 weekly ]
Same as current
Complete list of historical versions of study NCT00654446 on Archive Site
  • Renal effects of rosuvastatin and simvastatin [ Time Frame: 2 weekly ]
  • Low density lipoproteins cholesterol levels [ Time Frame: 2 weekly ]
  • Safety: adverse events & abnormal laboratory markers [ Time Frame: 2 weekly ]
Same as current
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IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
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
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
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fredrickson Type IIa & Type IIb Dyslipidaemia
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Drug: Simvastatin
    Other Name: Zocor
  • Experimental: 1
    Intervention: Drug: Rosuvastatin
  • Active Comparator: 2
    Intervention: Drug: Simvastatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Michael Cressman - Medical Science Director, AstraZeneca
Not Provided
Principal Investigator: Evan Stein Metabolic & Athersclerotic research centre, Cincinatti, USA
Study Director: Russell Esterline AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP