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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2022 |
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Main ID: |
NCT03092154 |
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Date of registration:
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09/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
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Scientific title:
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Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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24 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03092154 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Samuel K Shinjo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidade de Sao Paulo - Rheumatology Division |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- fullfill all criteria of Bohan and Peter (1975)
- 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:
Patients with:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Treatment Side Effects
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Intervention(s)
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Drug: Lipid-lowering agents (Artovastatin)
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Primary Outcome(s)
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Endothelial function
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Muscle enzymes
[Time Frame: 12 weeks]
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Health Assessment Questionnaire
[Time Frame: 12 weeks]
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Side effects
[Time Frame: 12 weeks]
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Myositis Disease Activity Assessment Tool
[Time Frame: 12 weeks]
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Manual Muscle Testing
[Time Frame: 12 weeks]
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Patient/Parent Global Activity
[Time Frame: 12 weeks]
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Physician Global Activity
[Time Frame: 12 weeks]
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Secondary ID(s)
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MYO-HCFMUSP-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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