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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557778
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : April 28, 2011
Information provided by:

Brief Summary:
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.

Condition or disease
Patients With Dyslipidemia

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia
Study Start Date : November 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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.

Primary Outcome Measures :
  1. Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557778

Research Site
Campinas, Sao Paulo, Brazil
Sponsors and Collaborators
Study Director: Jose Eduardo Neves, MD AstraZeneca Brazil Ltda
Principal Investigator: Francisco Jose Saraiva, MD PUC-Campinas

Responsible Party: Dr. Jose Eduardo Neves/Medical Director, AstraZeneca Identifier: NCT00557778     History of Changes
Other Study ID Numbers: NIS-CBR-CRE-2007/1
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases