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OpenTrials
Completed

NCT Number: NCT00557778

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Campinas, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: PRECAVER

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 14, 2007
Registry last updated
Apr 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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