Treatment of Hypercholesterolaemia in Hispanic Subjects (STARSHIP)

NCT ID: NCT00653965

Last Updated: 2009-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-02-28

Brief Summary

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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

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Conditions

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Hypercholesterolemia Dyslipidaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rosuvastatin

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

2

Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor Lipitor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Steve Haffner, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio, USA

Russell Esterline

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D3560L00027

Identifier Type: -

Identifier Source: secondary_id

4522US/0007

Identifier Type: -

Identifier Source: org_study_id

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