Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia

NCT ID: NCT00557778

Last Updated: 2011-04-28

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

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-09-30

Brief Summary

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Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in the group that will be exposed to the program of reinforcement of orientation aimed to the patients, compared to the control group, both in previous use of rosuvastatin.

Detailed Description

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Conditions

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Patients With Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Subjects eligible for the treatment of dyslipidemia with statins according the current guidelines NCEP ATPIII and IV Brazilian Guidelines of Dyslipidemia and Atherosclerosis Prevention.
* 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

Pregnancy and childbearing

* 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.
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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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

Site Status

Countries

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Brazil

Other Identifiers

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NIS-CBR-CRE-2007/1

Identifier Type: -

Identifier Source: org_study_id

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