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Trial record 1 of 1 for:    NCT01670136
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Pharmacokinetics of Sildenafil in Premature Infants

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ClinicalTrials.gov Identifier: NCT01670136
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : November 2, 2016
Sponsor:
Collaborators:
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 17, 2012
First Posted Date  ICMJE August 21, 2012
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Area under the plasma concentration versus time curve 0-24 hours for sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Peak plasma concentration of sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Clearance of sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Volume of distribution at steady state [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
  • Half life of sildenafil [ Time Frame: IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01670136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2012)
  • Number of subjects with adverse events as a measure of safety and tolerability. [ Time Frame: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of sildenafil to 7 days after the last dose of sildenafil ]
  • Correlation between serum and dried blood spot samples [ Time Frame: 1-7 days ]
  • Evaluate P450 single nucleotide polymorphisms (SNPs) [ Time Frame: 2-7 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2012)
  • Number of subjects with adverse events as a measure of safety and tolerability. [ Time Frame: From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of sildenafil ]
  • Correlation between serum and dried blood spot samples [ Time Frame: 1-7 days ]
  • Evaluate P450 single nucleotide polymorphisms (SNPs) [ Time Frame: 2-7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Sildenafil in Premature Infants
Official Title  ICMJE Pharmacokinetics of Sildenafil in Premature Infants
Brief Summary The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.
Detailed Description Pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Persistent Pulmonary Hypertension of the Newborn
Intervention  ICMJE Drug: 1 dose of sildenafil
A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.
Other Names:
  • Revatio
  • Viagra
Study Arms  ICMJE
  • No Intervention: sildenafil, standard of care
    Infants receiving sildenafil as standard of care
  • sildenafil administered for study
    1 dose of sildenafil administered for study
    Intervention: Drug: 1 dose of sildenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
34
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2012)
24
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Cohort 1:

  • Gestational age 28 weeks or less receiving sildenafil as standard of care < 365 postnatal days

Cohort 2:

  • Gestational age 28 weeks or less
  • 7-28 postnatal days of age
  • Mechanical ventilation or nasal continuous positive airway pressure (NCPAP) or high-flow nasal cannula
  • Intravenous line in place

Exclusion Criteria:

Cohort 1:

  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study

Cohort 2:

  • Previous exposure to sildenafil within 7 days prior to enrollment
  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • History of allergic reactions to sildenafil
  • AST > ULN or ALT > 3x ULN
  • Currently on a vasopressor for hypotension
  • Known sickle cell disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 364 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01670136
Other Study ID Numbers  ICMJE 11-1646
HHSN27500014 ( Other Grant/Funding Number: NICHD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Matthew M Laughon, MD, MPH University of North Carolina
PRS Account University of North Carolina, Chapel Hill
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP