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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
History of Changes
  Purpose

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
Dyslipidaemia
 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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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
  Eligibility

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

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

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

No publications provided

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:
cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Dyslipidemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
 Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013