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

Patients With Dyslipidemia Clinical Trial

— PRECAVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557778
• Other study ID #: NIS-CBR-CRE-2007/1
• Status: Completed
• Phase: N/A
• First received: November 13, 2007
• Last updated: April 27, 2011
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Not Required:
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidemias
• Patients With Dyslipidemia

Locations

Country	Name	City	State
Brazil	Research Site	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation
Secondary	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.