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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: |
NCT01941576 |
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Date of registration:
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03/09/2013 |
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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 rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
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Scientific title:
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Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot |
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Date of first enrolment:
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September 1, 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01941576 |
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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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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zhuoming Xu, MD,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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Shanghai Children's Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent obtained from patient's legally acceptable representative.
- Pediatric patients after Repair of Tetralogy Of Fallot.
Exclusion Criteria:
- Psychotic, addictive or other disorder limiting the ability to provide informed
consent or to comply with study requirements.
- Treatment or planned treatment with another investigational drug within 3 months of
screening.
- Known hypersensitivity to bosentan or any of the excipients
- cardiogenic shock and inclination of hypotension(SBP< 60mmHg).
Age minimum:
1 Month
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tetralogy Of Fallot
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Congenital Heart Defects
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Intervention(s)
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Drug: Placebo (0.9% sodium chloride)
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Drug: recombinant human brain natriuretic peptide (rhBNP)
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Primary Outcome(s)
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Changes from Baseline in BNP and CVP after the infusion of rhBNP
[Time Frame: 12 months after operation of Tetralogy Of Fallot]
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Secondary Outcome(s)
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Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen
[Time Frame: 12 months after operation of Tetralogy Of Fallot]
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Secondary ID(s)
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SJTUMS-20130903
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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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