MedPath

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

Completed
Conditions
Patients With Dyslipidemia
Registration Number
NCT00557778
Lead Sponsor
AstraZeneca
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
600
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.
Read More
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.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation
Secondary Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Research Site

🇧🇷

Campinas, Sao Paulo, Brazil

© Copyright 2025. All Rights Reserved by MedPath