Persistent Pulmonary Hypertension of the Newborn (PPHN) or Hypoxic Respiratory Failure and at Risk for PPHN
Conditions
Interventions
Trade Name: Revatio
Product Name: Revatio
Product Code: UK-92,480
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SILDENAFIL CITRATE
CAS Number: 139755-83-2
Other descriptive name: S
Sponsors
Pfizer, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent from legally acceptable guardian 2. PPHN or hypoxic respiratory failure associated with Idiopathic PPHN, Meconium aspiration syndrome, Respiratory distress syndrome, Sepsis, Pneumonia 3. Less than or equal to 72 hours of age 4. Greater than or equal to 34 week gestational age 5. Oxygenation index greater than or equal to (=)15 on 2 separate occasions calculated using blood gases taken at least 30 minutes apart prior to study drug infusion (Part1) or prior to randomization (Part 2) Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior use of inhaled nitrogen oxide (iNO) for Part 2 only (Prior use of iNO is allowed for Part 1 ) 2. Prior or immediate need for CPR (cardiopulmonary resuscitation) or ECMO (extracorporeal membrane oxygen) 3. Profound hypoxemia 4. Low pulmonary vascular resistance (PVR) as evidenced by large left to right intracardiac or ductal shunting based on the screening echocardiogram 5. Hypotension (mean arterial pressure [MAP] ] 2.5 × upper limit of normal [ULN]), hepatic function (Alanine Transferase [ALT] or Aspartate Amino Transferase [AST] > 3 × ULN or conjugated bilirubin > 2 × ULN), or haematological abnormalities: Severe anaemia (haemoglobin < 9 gram per decilitre [g/dl]), thrombocytopenia (platelets < 50,000 cells per micro millilitre [cells/mcl], or leucopenia (white blood cells < 2,500 cells/mcl) at the screening examination. 16. Known hereditary degenerative retinal disorders such as retinitis pigmentosa. 17. Symptoms of drug or alcohol related withdrawal. 18. Investigator’s discretion on a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the pharmacokinetics of intravenous (IV) sildenafil in near-term and term newborns with PPHN or with hypoxic respiratory failure and at risk for PPHN to determine doses for Part 2 of the study (Part1) 2. To determine the efficacy of IV sildenafil in near-term and term newborns with PPHN or with hypoxic respiratory failure and at risk for PPHN (Part 2 );Secondary Objective: 1. To assess the safety and tolerability of IV sildenafil as measured by clinical laboratory parameters, physical exam, vital signs (Blood Pressure [BP], Heart Rate [HR], Respiratory Rate [RR] and oxygen [O2] saturation), oxygenation index (OI), and the frequency and severity of adverse events (Parts 1 and 2) 2. To characterize the PK of sildenafil in newborns that have PPHN or hypoxic respiratory failure and at risk of developing PPHN. To describe the relationship between sildenafil concentration and the primary endpoint using a population pharmacokinetic-pharmacodynamic (PK-PD) model-based analysis (Part 2 only) 3. To evaluate the healthcare resource utilization associated with sildenafil therapy (Part 2 only) PART 2 was not conducted. ;Primary end point(s): Plasma Concentration of Sildenafil and UK-103320 Population Pharmacokinetics ;Timepoint(s) of evaluation of this end point: 5, 30 minutes post-infusion; every 24 hours from start of infusion; before end of infusion; at 1, 4, 8, 12, 24, 48, 72 hours post-infusion in Part 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A Part 2 was not conducted.;Timepoint(s) of evaluation of this end point: N/A Part 2 was not conducted. | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer, Inc.
Outcome results
None listed