EUCTR2014-004166-23-Outside-EU/EEA进行中（未招募）不适用
A 7-Day, Open-Label, Multicenter, Pharmacokinetic (PK) Study (Part 1) Followed by A 7-Day, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study (Part 2) of Intravenous (IV) Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) or Hypoxic Respiratory Failure and at Risk for PPH
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer, Inc.
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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] <35 mm Hg) or shock any time during screening
- •6. Life threatening or lethal congenital anomaly
- •7. Congenital heart disease exclusive of interatrial communication or patent ductus arteriosus
- •8. Lung hypoplasia syndromes diagnosed on the basis of prolonged oligohydramnios or hydrops fetalis
- •9. Congenital diaphragmatic hernia
- •10. Active seizures (within 12 hours of study drug infusion [Part 1] or randomization Part 2])
- •11. Apgar score of <3 at 5 minutes after birth
- •12. Bleeding diathesis
- •13. Receipt of any other experimental drug or device
- •14. Receipt of any prohibited concurrent medication/therapy at any time prior to randomization: Potent cytochrome P450 3A4 inhibitors (example, erythromycin, ketoconazole, itraconazole, and protease inhibitors), Ritonavir or Nicorandil, Endothelin antagonists (example tracleer, bosentan), Nitrates or Nitric Oxide (NO) donors in any form, except the prior or concurrent use of iNO. (subject would be eligible if nitroprusside was used, only if it was discontinued at least 2 hours prior to study drug infusion),Vasodilators (example alpha blockers, magnesium sulfate, calcium channel blockers, other phosphodiesterase inhibitors, prostacyclins, etc), excluding milrinone, which was allowed during as concurrent therapy, Supplemental arginine administered for the purpose of improving NO-dependent vasodilation. (maintenance quantities in total parental nutrition were allowed), Open-label sildenafil other than study drug.
- •15. Impairment of renal function (serum creatinine greater than [>] 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.
研究者
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