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

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ClinicalTrials.gov Identifier: NCT00654602
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : May 28, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidaemia Drug: Rosuvastatin Behavioral: Maintenance of specific diet Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2002
Actual Study Completion Date : November 2004



Intervention Details:
    Drug: Rosuvastatin
    Other Name: Crestor
    Behavioral: Maintenance of specific diet


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

Secondary Outcome Measures :
  1. Reduction in low density lipoprotein cholesterol levels [ Time Frame: 24 & 48 weeks ]
  2. Safety: adverse events & abnormal laboratory markers [ Time Frame: 4 weekly until week 12 then 12 weekly thereafter. ]
  3. Maintenance of lowered low density lipoprotein cholesterol level [ Time Frame: Between week 12-48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654602


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

ClinicalTrials.gov Identifier: NCT00654602     History of Changes
Other Study ID Numbers: 4522IL/0091
D3560C00091
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor

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