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Treatment of Hypercholesterolaemia in Hispanic Subjects (STARSHIP) (STARSHIP)

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ClinicalTrials.gov Identifier: NCT00653965
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : March 16, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in Hispanic subjects with hypercholesterolemia

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dyslipidaemia Drug: Rosuvastatin Drug: Atorvastatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in Hispanic Subjects.
Study Start Date : May 2003
Actual Study Completion Date : February 2005

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Rosuvastatin
 Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Atorvastatin
 Drug: Atorvastatin
Other Name: Lipitor


Outcome Measures
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Primary Outcome Measures :
  1. Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Other blood lipid level changes [ Time Frame: 6 weeks ]
  2. Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fasting low density lipoprotein & triglyceride levels as defined by the protocol.
  • Self described Hispanic race
  • Subjects with coronary heart disease or at high risk of coronary heart disease.

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
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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): NCT00653965


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Steve Haffner, MD San Antonio, USA
Study Director: Russell Esterline AstraZeneca
More Information
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Responsible Party: Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier: NCT00653965    
Other Study ID Numbers: 4522US/0007
D3560L00027
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
 Crestor
Atorvastatin
Lipitor
Hispanic
Additional relevant MeSH terms:
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Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin Calcium
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors