Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

NCT01069861 | Terminated Phase 2 Results DMC

• 1 other identifier: A1481276
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

Conditions

PPHN; Persistent Pulmonary Hypertension of the Newborn; Hypoxic Respiratory Failure

Keywords

PPHN; neonates; sildanefil IV

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO)

  Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment.

  From start of infusion (baseline) up to Day 14

• Number of Participants With Adverse Events (AEs) Based on Severity

  AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE:AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent/significant disability/incapacity; congenital anomaly. Severity criteria: "mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function and severe=interferes significantly with participant's usual function".

  Baseline up to 28 days after last dose

• Number of Participants With Abnormal Laboratory Data

  Criteria for potentially clinically significant (PCS) laboratory values: hematocrit 29.2 percent (%); white blood cell (WBC) count 5.0\*10\^3, lymphocyte absolute 0.88\*10\^3, total neutrophils absolute 12.07\*10\^3, eosinophils absolute 0.50\*10\^3 per cubic millimeter (/mm\^3); calcium 6.8 milligram/deciliter (mg/dL); venous bicarbonate 47.0 milliequivalent/liter (meq/L).

  Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14)

Secondary Outcomes (7)

• Change From Baseline in Oxygenation Index at Hour 6 and 12

  Baseline, Hour 6, 12

• Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12

  Baseline, Hour 6, 12

• Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12

  Baseline, Hour 6, 12

• Duration of Mechanical Ventilation

  Baseline up to 28 days after last dose

• Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO])

  Baseline up to 28 days after last dose

Other Outcomes (1)

• Duration of Study Medication

  Baseline up to Day 14

Study Arms (1)

one

EXPERIMENTAL

Drug: sildanefil

Interventions

sildanefil DRUG

Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.

one

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• hours of age; and \> or = to 34 weeks gestational age.
• Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure associated with:
• Idiopathic PPHN or
• Meconium aspiration syndrome or
• Sepsis or
• Pneumonia
• Oxygenation Index (OI) \>15 and \<60 calculated

You may not qualify if:

• Patients already receiving inhaled nitric oxide (iNO) on referral.
• Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal Membrane Oxygenation (ECMO).
• Life threatening or lethal congenital anomaly.
• Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on admission to GOSH).
• Clinically significant active seizures as per clinical judgment.
• Bleeding diathesis as per clinical judgment

Sponsors & Collaborators

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

Study Sites (1)

Great Ormond Street Hospital, Paediatric Intensive Care

London, WC1N 3JH, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The study was prematurely discontinued, therefore not all data was analyzed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 1, 2021
• Results First Posted: December 3, 2012

Record last verified: 2021-01

Locations

GB (1)