Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia
NCT ID: NCT00557778
Last Updated: 2011-04-28
Study Results
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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COMPLETED
600 participants
OBSERVATIONAL
2007-11-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Receives treatment with rosuvastatin, according to International and National Guidelines on hypercholesterolemia.
No interventions assigned to this group
Group 2
Receives the same treatment as group 1 and information on health improvement, diet and exercises applied to the disease that is being treated. The positive impact of the information upon treatment will be statistically evaluated.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with previous use of rosuvastatin for, at least, 15 days and, for no longer than12 months prior to the inclusion in the study.
Exclusion Criteria
* History of severe hypersensitivity (including myopathy) to other HMG-CoA reductase inhibitors.
* Subjects with indication of use of cyclosporine and other associations of other lipid lowering drugs.
* Subjects with underlying diseases that may influence lipid levels (i.e. uncontrolled hypothyroidism defined as a Thyroid stimulating hormone (TSH) \> 1.5 times upper level of normality (ULN) at Visit 1, AIDS, transplanted subjects, etc).
* History of drug and alcohol abuse.
* Current active liver disease or hepatic failure or elevations in ALT \>3 times the ULN.
* Elevation of CPK \> 3 times the ULN.
* Elevation in the seric creatinine \> 2,0 mg / dL.
* History of malignancy in the last 5 years, except basal cell or squamous cell carcinoma of the skin (women with a history of Cervical dysplasia must be included, unless they have t3 clear consecutive Papanicolaou (Pap) smears , before the entry in the study).
* Any other known clinical condition that, in the opinion of the investigator, may compromise the subject's safety.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Jose Eduardo Neves, MD
Role: STUDY_DIRECTOR
AstraZeneca Brazil Ltda
Francisco Jose Saraiva, MD
Role: PRINCIPAL_INVESTIGATOR
PUC-Campinas
Locations
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Research Site
Campinas, São Paulo, Brazil
Countries
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Other Identifiers
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NIS-CBR-CRE-2007/1
Identifier Type: -
Identifier Source: org_study_id
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