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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00557778
First received: November 13, 2007
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

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
Patients With Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 600
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557778

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

No publications provided

Responsible Party: Dr. Jose Eduardo Neves/Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00557778     History of Changes
Other Study ID Numbers: NIS-CBR-CRE-2007/1
Study First Received: November 13, 2007
Last Updated: April 27, 2011
Health Authority: Not Required:

Keywords provided by AstraZeneca:
prevention
dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 23, 2014