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.
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation
- Secondary Outcome Measures
Name Time Method Assess cardiovascular risk through Framingham's score, 路 路 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
馃嚙馃嚪Campinas, Sao Paulo, Brazil