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

NCT00557778 | Completed

• 1 other identifier: NIS-CBR-CRE-2007/1
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Dyslipidemia

Keywords

prevention; dyslipidemia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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.

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• Subjects eligible for the treatment of dyslipidemia with statins according the current guidelines NCEP ATPIII and IV Brazilian Guidelines of Dyslipidemia and Atherosclerosis Prevention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jose Eduardo Neves, MD

  AstraZeneca Brazil Ltda

  STUDY DIRECTOR

• Francisco Jose Saraiva, MD

  PUC-Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 28, 2011

Record last verified: 2011-04

Locations

BR (1)