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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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12 December 2020 |
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Main ID: |
NCT02354352 |
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Date of registration:
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27/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
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Scientific title:
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Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy |
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Date of first enrolment:
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March 20, 2015 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02354352 |
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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Subha V Raman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Boys age =7 years with DMD confirmed clinically and by mutation analysis able to
undergo cardiac magnetic resonance (CMR) without sedation
- LV EF =45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac
MRI done within 2 weeks of enrollment
Exclusion Criteria:
- Non-MR compatible implants
- Severe claustrophobia
- Gadolinium contrast allergy
- Kidney disease
- Prior use of or allergy to aldosterone antagonist
- Use of other investigational therapy.
Age minimum:
7 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy
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Intervention(s)
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Drug: Eplerenone
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Drug: Spironolactone
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Primary Outcome(s)
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Left Ventricular Strain
[Time Frame: 12 months]
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Secondary ID(s)
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2014H0387
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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