Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia (PRECAVER)

April 27, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Patients With Dyslipidemia

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- Sao Paulo
  - Campinas, Sao Paulo, Brazil
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care Clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Receives treatment with rosuvastatin, according to International and National Guidelines on hypercholesterolemia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation

Secondary Outcome Measures

Outcome Measure
Assess cardiovascular risk through Framingham's score, · · Identify personal characteristics of the study population regarding their health, compile demographic characteristics regarding education, economic and cultural status.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Jose Eduardo Neves, MD, AstraZeneca Brazil Ltda
Principal Investigator: Francisco Jose Saraiva, MD, PUC-Campinas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria