Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia (PRECAVER)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00557778
First received: November 13, 2007
Last updated: April 27, 2011
Last verified: April 2011
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Purpose
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.
| Condition |
|---|
|
Patients With Dyslipidemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation
Secondary Outcome Measures:
- 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.
| Enrollment: | 600 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Primary Care Clinic
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557778
Locations
| Brazil | |
| Research Site | |
| Campinas, Sao Paulo, Brazil | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jose Eduardo Neves, MD | AstraZeneca Brazil Ltda |
| Principal Investigator: | Francisco Jose Saraiva, MD | PUC-Campinas |
More Information
No publications provided
| Responsible Party: | Dr. Jose Eduardo Neves/Medical Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00557778 History of Changes |
| Other Study ID Numbers: | NIS-CBR-CRE-2007/1 |
| Study First Received: | November 13, 2007 |
| Last Updated: | April 27, 2011 |
| Health Authority: | Not Required: |
Keywords provided by AstraZeneca:
|
prevention dyslipidemia |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013