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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00653965

First received: March 26, 2008

Last updated: March 13, 2009

Last verified: March 2009

History of Changes

Purpose

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	Intervention	Phase
Hypercholesterolemia Dyslipidaemia	Drug: Rosuvastatin Drug: Atorvastatin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin Atorvastatin calcium trihydrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Low density lipoproteins cholesterol levels [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Other blood lipid level changes [ Time Frame: 6 weeks ]
Safety: adverse events & abnormal laboratory markers [ Time Frame: 6 weeks ]


Estimated Enrollment:	3000
Study Start Date:	May 2003
Study Completion Date:	February 2005

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin	Drug: Rosuvastatin Other Name: Crestor
Active Comparator: 2 Atorvastatin	Drug: Atorvastatin Other Name: Lipitor

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653965

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Steve Haffner, MD	San Antonio, USA
Study Director:	Russell Esterline	AstraZeneca

More Information


Responsible Party:	Elisabeth Björk, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00653965 History of Changes
Other Study ID Numbers:	4522US/0007 D3560L00027
Study First Received:	March 26, 2008
Last Updated:	March 13, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


Cholesterol low density lipoproteins dyslipidaemia Rosuvastatin	Crestor Atorvastatin Lipitor Hispanic

Additional relevant MeSH terms:


Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Rosuvastatin Calcium	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

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