48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654602
First received: April 3, 2008
Last updated: May 27, 2009
Last verified: May 2009

April 3, 2008
May 27, 2009
February 2002
Not Provided
Reduction in low density lipoprotein cholesterol levels [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00654602 on ClinicalTrials.gov Archive Site
  • Reduction in low density lipoprotein cholesterol levels [ Time Frame: 24 & 48 weeks ]
  • Safety: adverse events & abnormal laboratory markers [ Time Frame: 4 weekly until week 12 then 12 weekly thereafter. ]
  • Maintenance of lowered low density lipoprotein cholesterol level [ Time Frame: Between week 12-48 ]
Same as current
Not Provided
Not Provided
 
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyslipidaemia
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Behavioral: Maintenance of specific diet
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
November 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 lipid levels above the limits defined in the protocol.
  • 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
 
NCT00654602
4522IL/0091, D3560C00091
Not Provided
Not Provided
AstraZeneca
Not Provided
Principal Investigator: Dr. Evan Stein Metabolic & Athersclerotic research centre, USA
Study Director: Russell Esterline AstraZeneca
AstraZeneca
May 2009

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