STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

NCT ID: NCT00654537

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

5625 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2004-10-31

Brief Summary

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To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

Detailed Description

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Conditions

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Hypercholesterolemia

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

3

Pravastatin

Group Type ACTIVE_COMPARATOR

Pravastatin

Intervention Type DRUG

4

Simvastatin

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Pravastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Other Intervention Names

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Crestor Lipitor Lipostat Zocor

Eligibility Criteria

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Inclusion Criteria

* Discontinuation of all previous lipid lowering therapy.
* Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 \& 3 for subjects not on lipid lowering therapy at Visit 1.
* Other lipid parameters as specified in 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
* Abnormal laboratory parameters as defined in the protocol.
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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Eleanor Miller, MD

Role: STUDY_DIRECTOR

AstraZeneca

Russell Esterline

Role: STUDY_CHAIR

AstraZeneca

Other Identifiers

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D3560C00065

Identifier Type: -

Identifier Source: secondary_id

4522IL/0065

Identifier Type: -

Identifier Source: org_study_id

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