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IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009

April 3, 2008
March 13, 2009
September 2002
Not Provided
Development of Proteinuria [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00654446 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   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.
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
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