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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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30 October 2017 |
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Main ID: |
NCT03076814 |
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Date of registration:
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23/09/2014 |
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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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Functional Muscle Ischemia With Tadalafil Treatment in Becker Muscular Dystrophy
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Scientific title:
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Date of first enrolment:
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March 2012 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03076814 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Key inclusion & exclusion criteria
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Patient with BMD -
Inclusion Criteria:
- diagnosis of BMD confirmed by muscle biopsy or DNA analysis
- age 15-55 years of age
- ambulatory
- no clinical evidence of heart failure
Exclusion Criteria:
- hypertension, diabetes, or heart failure by standard clinical criteria
- elevated BNP (brain natriuretic peptide) level (>100 pg/ml)
- left ventricular ejection fraction < 50%
- wheelchair bound
- cardiac rhythm disorder, specifically: rhythm other than sinus, sinoventricular
tachycardia, atrial fibrillation, ventricular tachycardia
- continuous ventilatory support
- liver disease
- renal impairment
- contraindications to tadalafil (use of nitrates, alpha-blockers, Cytochrome P450
(CYP3A )inhibitors, amlodipine, or other phosphodiesterase 5A inhibitors)
Healthy Control Participants -
Inclusion Criteria:
- age 15-55 years of age
- ambulatory
- no clinical evidence of heart failure
Exclusion Criteria:
- hypertension, diabetes, or heart failure by standard clinical criteria
- elevated BNP (brain natriuretic peptide) level (>100 pg/ml)
- left ventricular ejection fraction < 50%
- cardiac rhythm disorder, specifically: rhythm other than sinus, sinoventricular
tachycardia, atrial fibrillation, ventricular tachycardia
- liver disease
- renal impairment
- unsatisfactory completion of the sympatholysis protocol
- BMI < 35
Age minimum:
15 Years
Age maximum:
55 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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Drug: Tadalafil
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Other: Placebo
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Primary Outcome(s)
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Change in post-exercise muscle edema by MRI.
[Time Frame: Pre vs. 48 hours post treatment change]
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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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