NCT03013751已完成3 期
A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 24
- 主要终点
- Treatment-Emergent Adverse Events
研究概览
简要总结
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
详细描述
This will be an open-label extension study. All enrolled subjects will be provided with udenafil for the duration of the study. Subjects completing the Phase III FUEL study will be eligible for recruitment. Additional subjects will be recruited as needed to ensure a minimum of 300 total subjects enroll. Safety, pharmacodynamic and quality of life data will be collected and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with Fontan physiology who participated in the FUEL trial or, if they did not participate in FUEL, those who are 12 to less than 19 years of age at enrollment.
- •Participant consent or parental/guardian consent and participant assent.
- •Participant fluent in English, Spanish, or Korean.
- •Current anti-platelet or anticoagulant therapy.
排除标准
- •Height < 132 cm.
- •Weight < 40 kg.
- •Hospitalization for acute decompensated heart failure within the last 12 months.
- •Current intravenous inotropic drugs.
- •Undergoing evaluation for heart transplantation or listed for transplantation.
- •Diagnosis of active protein losing enteropathy or plastic bronchitis within the last three years, or a history of liver cirrhosis.
- •Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of > 4 mm Hg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography.
- •Single lung physiology.
- •Maximal VO2 less than 50% of predicted for age and gender at enrollment.
- •Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
- •Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
- •Significant renal, hepatic, gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications.
- •Inability to complete exercise testing at baseline screening.
- •History of PDE-5 inhibitor use (with the exception of FUEL participation) within 3 months before study onset.
- •Use of any other drug to treat pulmonary hypertension within 3 months before study onset.
- •Known intolerance to oral udenafil.
- •Frequent use of medications or other substances that inhibit or induce CYP3A
- •Current use of alpha-blockers or nitrates.
- •Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
- •Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
- •Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
- •For females: Pregnancy at the time of screening, pregnancy planned before study completion, or refusal to use an acceptable method of contraception for study duration.
- •Unable to abstain or limit intake of grapefruit juice during the duration of the trial.
- •Refusal to provide written informed consent/assent.
- •In the opinion of the primary care physician, the subject is likely to be non-compliant with the study protocol.
- •History of clinically significant thromboembolic event, as adjudicated by study Investigators.
研究组 & 干预措施
Drug
Experimental
Udenafil administered for 52 weeks
干预措施: Udenafil (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Events
时间窗: 52 Weeks
Summary of Treatment Emergent Adverse Events
次要结局
- Change in Maximal VO2(52 Weeks)
- Change in Log-transformed Reactive Hyperemia Index (lnRHI)(52 Weeks)
- Change in Serum BNP(52 Weeks)
- Change in Myocardial Performance Index (MPI)(52 Weeks)
- Change in PedsQL Physical Functioning (Child Reported)(52 Weeks)
- Change in PedsQL Physical Functioning (Parent Reported)(52 Weeks)
- Change in PedsQL Psychosocial Health Summary Score (Child Reported)(52 Weeks)
- Change in PedsQL Psychosocial Health Summary Score (Parent Reported)(52 Weeks)
- Change in PedsQL Functional Health Status Score (Child Reported)(52 Weeks)
- Change in PedsQL Functional Health Status Score (Parent Reported)(52 Weeks)
研究者
研究点 (24)
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