Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)

NCT ID: NCT00660764

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

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-04-30

Brief Summary

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In an observational multi-centre study (HEROS), the effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who had not been treated with cholesterol lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.

Detailed Description

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Conditions

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Hypercholesterolemia Coronary Heart Disease Peripheral Vascular Disease Cerebrovascular Accident Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients eligible for the study were patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C ≥ 3.2 mmol/l. Patients were aged ≥ 18 years and ≤ 70 years (men) and ≤ 75 years (women), according to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention. The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca

Rosuvastatin

Intervention Type DRUG

Oral

Interventions

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Rosuvastatin

Oral

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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Inclusion Criteria

* patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C 3.2 mmol/l.
* According to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention.
* The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation.
* Patient approved to place anonymous results at the disposal of AstraZeneca

Exclusion Criteria

* Patients with symptoms of myalgia, myopathy or liver function insufficiency (including raised serum transaminases) which bear a causal relation to the treatment with statins, patients with familiar dyslipidemia and/or patients with contra-indications for treatment with rosuvastatin
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Ingrid van Geel

Role: STUDY_CHAIR

CV

Ingeborg Vosjan

Role: STUDY_CHAIR

CV

Other Identifiers

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25V07

Identifier Type: -

Identifier Source: org_study_id

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