Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

NCT ID: NCT00695539

Last Updated: 2009-10-05

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

Total Enrollment

810 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.

Detailed Description

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Conditions

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Hypercholesterolaemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry
* Patients that are able to read, understand and sign the Patient Information \& Consent Form
* Patients that are willing to comply with all study requirements

Exclusion Criteria

* Patients that are likely not to comply with all study requirements
* Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial
* Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation.
* Patients that meet any of the contraindications described in the approved SPC
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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 S.A., Greece

Locations

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Research Site

Alexandroupoli, , Greece

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Iraklio, Crete, , Greece

Site Status

Research Site

Larissa, , Greece

Site Status

Research Site

Rio, Patra, , Greece

Site Status

Research Site

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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NIS-CGR-CRE-2007/1

Identifier Type: -

Identifier Source: org_study_id

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