48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

NCT ID: NCT00654602

Last Updated: 2009-05-28

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

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2004-11-30

Brief Summary

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The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Detailed Description

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Conditions

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Dyslipidaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosuvastatin

Intervention Type DRUG

Maintenance of specific diet

Intervention Type BEHAVIORAL

Other Intervention Names

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Crestor

Eligibility Criteria

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Inclusion Criteria

* Fasting low density lipoprotein level as defined by the protocol.
* Fasting triglyceride level as defined by the protocol.

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

Principal Investigators

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Dr. Evan Stein

Role: PRINCIPAL_INVESTIGATOR

Metabolic & Athersclerotic research centre, USA

Russell Esterline

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

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D3560C00091

Identifier Type: -

Identifier Source: secondary_id

4522IL/0091

Identifier Type: -

Identifier Source: org_study_id

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