Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease

NCT ID: NCT00235950

Last Updated: 2010-11-19

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

PHASE4

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to compare the efficacy between two lipid lowering treatments, rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart disease

Detailed Description

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Conditions

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Coronary Heart Disease

Keywords

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Coronary Heart Disease Percutaeous Coronary Intervention (PCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Rosuvastatin or atorvastatin or simvastatin and clopidogrel

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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Inclusion Criteria

* 18 years or older, established coronary heart disease with a previously performed PCI, previous treatment with clopidogrel, ongoing statin treatment, LDL-C\>2.9 mmol/L, signed informed consent.

Exclusion Criteria

* Ongoing treatment with clopidogrel for more than 12 weeks after randomisation, hypersensitivity to any of the study drugs, active liver disease, moderate or severe renal impairment, hereditary for or known muscular or neuromuscular disease and/or increased serum CK, pregnancy or lactation or of childbearing potential not practising an adequate method of contraception, use of concomitant medication with possible interaction with
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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AstraZeneca Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Danderyd, , Sweden

Site Status

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Eksjö, , Sweden

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Falun, , Sweden

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Gothenburg, , Sweden

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Helsingborg, , Sweden

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Jönköping, , Sweden

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Karlskrona, , Sweden

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Karlstad, , Sweden

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Ljungby, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Örebro, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Sundsvall, , Sweden

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Uppsala, , Sweden

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Vaxjo, , Sweden

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Västerås, , Sweden

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Countries

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Sweden

Other Identifiers

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D3560L00039

Identifier Type: -

Identifier Source: org_study_id