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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653965
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : March 16, 2009
Information provided by:

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

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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

Arm Intervention/treatment
Experimental: 1
Drug: Rosuvastatin
Other Name: Crestor

Active Comparator: 2
Drug: Atorvastatin
Other Name: Lipitor

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 ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00653965

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