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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: |
NCT02147639 |
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Date of registration:
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25/03/2014 |
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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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Effects of Sodium Nitrate on Blood Flow in Becker Muscular Dystrophy
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Scientific title:
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Date of first enrolment:
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October 2013 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02147639 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2/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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Ronald G Victor, 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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Cedars-Sinai Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men 15-55 years of age with a pre-existing diagnosis of Becker Muscular Dystrophy by a
clinical neurologist (based on clinical criteria plus previous muscle biopsy analysis
and/or DNA analysis).
Exclusion Criteria:
- Any evidence of cardiopulmonary disease by history or by physical examination
- History of hypertension or blood pressure averaging =140/90 mmHg
- Diabetes mellitus or other systemic illness
- Heart failure by clinical exam, elevated BNP, or heart failure medication
- Serum creatinine = 1.5 mg/dL
- Any history of substance abuse (including alcohol)
- Any history of psychiatric illness
Age minimum:
15 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Becker Muscular Dystrophy
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Intervention(s)
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Dietary Supplement: Sodium Nitrate
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Dietary Supplement: Placebo
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Procedure: Increased exercise intensity
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Dietary Supplement: Sodium Nitrate - double dose
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Primary Outcome(s)
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Skeletal muscle blood flow
[Time Frame: 24 hours after initial visit]
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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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