Patients With DyslipidemiaPRECAVERNCT00557778
Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia
An observational study of Patients With Dyslipidemia, run by AstraZeneca at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Dyslipidemia
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With DyslipidemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jose Eduardo Neves, MD, Study director, AstraZeneca Brazil LtdaFrancisco Jose Saraiva, MD, Principal investigator, PUC-Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557778
- Sponsor's protocol ID
- NIS-CBR-CRE-2007/1
- Acronym
- PRECAVER
- Status last verified
- Apr 2011
- First submitted
- 13 Nov 2007
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia
- ClinicalTrials.gov ID
- NCT00557778
- Acronym / sponsor ID
- PRECAVER / NIS-CBR-CRE-2007/1
- Conditions
- Patients With Dyslipidemia
- Keywords
- prevention, dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Eduardo Neves, MD study director
AstraZeneca Brazil Ltda
Francisco Jose Saraiva, MD principal investigator
PUC-Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Dyslipidemia, run by AstraZeneca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the LDL-C reduction in the group exposed to the educational program compared to the group with routine orientation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.