Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
NCT ID: NCT03092154
Last Updated: 2022-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
24 participants
INTERVENTIONAL
2017-01-31
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Exposed
Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks
Lipid-lowering agents (Artovastatin)
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
No intervention
Patients will not receive artovastatin (lipid-lowering agents)
No interventions assigned to this group
Interventions
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Lipid-lowering agents (Artovastatin)
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* dyslipidemia
* age\> 18 years
* prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months
* without changing nutritional habits in the last three months, and during the study period
* no change of lifestyle in the last three months, and during the study period
Exclusion Criteria
* disease relapsing
* overlapping myositis
* neoplasia associated myositis
* diabetes mellitus
* current and/or chronic infections
* patients undergoing major surgery within six months prior to the study
* pregnant patients
* previous use of lipid-lowering agents in the last 6 months
* in the use of cyclosporin, erythromycin, clarithromycin, fibrates, niacin, azole antifungals, cimetidine, diltiazem
* active liver disease or persistent elevations of hepatic enzymes, with no apparent cause, exceeding three times the upper limit of normality
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Samuel Katsuyuki Shinjo, PhD
Principal Investigator
Principal Investigators
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Samuel K Shinjo, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade de Sao Paulo - Rheumatology Division
Locations
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Samuel Katsuyuki Shinjo
São Paulo, , Brazil
Countries
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Other Identifiers
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MYO-HCFMUSP-03
Identifier Type: -
Identifier Source: org_study_id
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