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

Tracking Information
First Submitted Date  ICMJE March 26, 2008
First Posted Date  ICMJE April 7, 2008
Last Update Posted Date March 16, 2009
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
  • Other blood lipid level changes [ Time Frame: 6 weeks ]
  • Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hypercholesterolaemia in Hispanic Subjects (STARSHIP)
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Dyslipidaemia
Intervention  ICMJE
  • Drug: Rosuvastatin
    Other Name: Crestor
  • Drug: Atorvastatin
    Other Name: Lipitor
Study Arms  ICMJE
  • Experimental: 1
    Rosuvastatin
    Intervention: Drug: Rosuvastatin
  • Active Comparator: 2
    Atorvastatin
    Intervention: Drug: Atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 4, 2008)
3000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00653965
Other Study ID Numbers  ICMJE 4522US/0007
D3560L00027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elisabeth Björk, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steve Haffner, MD San Antonio, USA
Study Director: Russell Esterline AstraZeneca
PRS Account AstraZeneca
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP