NL-OMON37174已完成3 期
A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT - A1481316 (207824)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator*s study team before subjects are included in the study.
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. PPHN or hypoxic respiratory failure (HRF) at risk for PPHN associated with:
- •* Idiopathic PPHN;
- •* Meconium aspiration syndrome;
- •* Sepsis; or
- •* Pneumonia.
- •2. *72 hours of age and *34 weeks of gestation at screening.
- •3. OI >15 and <60, calculated using two blood gases taken at least 30 minutes apart prior to randomization and start of study drug infusion.
- •4. Concurrent treatment with iNO at 10-20 ppm on *50% oxygen.
- •5. Screening echocardiogram, within 24 hours of study start, to confirm presence of pulmonary hypertension for continued participation in the trial.
- •6. Screening cranial ultrasound, within 24 hours of study start, to eliminate patients with clinically significant intracranial bleeds per investigator judgment.
- •7. Evidence of a personally signed and dated informed consent document indicating that the subject*s legal representative has been informed of all pertinent aspects of the study; and
- •8. Subjects whose legal representative is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Prior or immediate need for ECMO or CPR.
- •2. Expected duration of mechanical ventilation of less than 48 hours.
- •3. Life-threatening or lethal congenital anomaly.
- •4. Profound hypoxemia: PaO2 <30 mm Hg on any arterial blood gas drawn within 30 minutes of starting study drug infusion.
- •5. Severe hypotension at baseline (mean arterial pressure (MAP) <30 mmHg) not responsive to medical management, or shock any time during screening.
- •6. Significant congenital heart disease or defect exclusive of inter-atrial communication or patent ductus arteriosus.
- •7. Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram within 24 hours of admission).
- •8. Large clinically significant intracranial bleed (diagnosed from cranial ultrasound within 24 hours of admission).
- •9. Lung hypoplasia syndromes diagnosed on the basis of prolonged oligohydramnios or hydrops faetalis.
- •10. Congenital diaphragmatic hernia.
- •11. Clinically significant active seizures, as per clinical judgment of the investigator.
- •12. Apgar score of <3 at 5 minutes after birth.
- •13. Bleeding diathesis, as per clinical judgment of the investigator.
- •14. Receipt of any prohibited concurrent medication/therapy at any time prior to screening:
- •* Potent cytochrome P450 3A4 inhibitors (eg, erythromycin, ketoconazole, itraconazole, and protease inhibitors), erythromycin ophthalmic ointment is allowed;
- •* Ritonavir or nicorandil;
- •* Endothelin antagonists (eg, Tracleer (RTM)/bosentan, Letairis(RTM)/ambristan, etc);
- •* PDE5 inhibitors (eg, sildenafil, tadalafil, vardenafil), IV or per orogastric tube;
- •* Nitrates or nitric oxide donors, except iNO (A subject is eligible if nitroprusside was used only if it was discontinued at least 2 hours prior to study drug infusion; iNO may be used per protocol);
- •* Vasodilators (eg, alpha blockers, magnesium sulfate as infusion, calcium channel blockers, other PDE inhibitors, prostacyclins, etc) at study entry (Excludes milrinone, which is allowed during the study as concurrent therapy) at study entry; or
- •* Supplemental arginine administered for the purpose of improving NO-dependent vasodilation (Maintenance quantities in total parental nutrition (TPN) are allowed).
- •15. Known hereditary degenerative retinal disorders, such as retinitis pigmentosa.
- •16. Symptoms of drug- or alcohol-related withdrawal.
- •17. In the opinion of the investigator, a subject inappropriate for the study for any reason.
- •18. Other acute or severe medical conditions, or marked laboratory abnormalities that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •19. Participation in any other experimental studies involving other drug or non-interventional therapies before the current study begins and/or during study participation.
- •Subjects who are relatives of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
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