IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654446
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 ClinicalTrials.gov 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
Interventional
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
    Rosuvastatin
    Intervention: Drug: Rosuvastatin
  • Active Comparator: 2
    Simvastatin
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00654446
4522IL/0099
Not Provided
Michael Cressman - Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Evan Stein Metabolic & Athersclerotic research centre, Cincinatti, USA
Study Director: Russell Esterline AstraZeneca
AstraZeneca
March 2009

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