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A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

NCT01720524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-08-16

Study results available
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Summary

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Conditions

  • Pulmonary Hypertension, Familial Persistent, of the Newborn

Interventions

DRUG

placebo

IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.

DRUG

iv sildenafil

loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
4 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-05
Primary Completion
2018-10-17
Completion
2020-09-28

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720524 on ClinicalTrials.gov