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

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

Condition Intervention Phase
Drug: Rosuvastatin
Behavioral: Maintenance of specific diet
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Reduction in low density lipoprotein cholesterol levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1500
Study Start Date: February 2002
Study Completion Date: November 2004
Intervention Details:
    Drug: Rosuvastatin
    Other Name: Crestor
    Behavioral: Maintenance of specific diet

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654602

Sponsors and Collaborators
Principal Investigator: Dr. Evan Stein Metabolic & Athersclerotic research centre, USA
Study Director: Russell Esterline AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00654602     History of Changes
Other Study ID Numbers: 4522IL/0091  D3560C00091 
Study First Received: April 3, 2008
Last Updated: May 27, 2009
Health Authority: Australia: National Health and Medical Research Council
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
low density lipoproteins

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016