EUCTR2011-001873-24-ES进行中（未招募）1 期
A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
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
- •Pediatric patients (?6 months to <18 years of age) at time of screening with confirmed PAH.
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •[1] ?6 months to <18 years of age (at screening).
- •[2] Currently have a diagnosis of PAH that is either:
- •- idiopathic,
- •- related to collagen vascular disease,
- •- related to anorexigen use,
- •- associated with an atrial-ventricular septal defect (with resting arterial oxygen saturation ?88% on room air at screening), or with surgical repair, of at least 6 month duration, of a congenital systemic-to pulmonary shunt (for example, ventricular septal defect, patent ductus arteriosus).
- •[3] Have a history of the diagnosis of PAH established by a resting mean pulmonary artery pressure ?25 mm Hg, pulmonary artery wedge pressure ?15 mm Hg, and a pulmonary vascular resistance (PVR) ?3 Wood units via right heart catheterization within 1 year of
- •screening. In the event that a pulmonary artery wedge pressure is unable to be obtained during right heart catheterization, patients with a left ventricular end diastolic pressure ?15 mm Hg, with normal left heart function, and absence of mitral stenosis on echocardiography can be eligible for enrollment.
- •[4] Have a WHO functional class value of I, II or III at the time of enrollment.
- •[5] If on an ERA (that is, bosentan or ambrisentan), must be on a maintenance dose, with no change in dose (other than weight-based adjustments) for ?12 weeks prior to screening and have a screening aspartate transaminase (AST) or alanine transaminase (ALT) <3 times the upper limit of normal.
- •[6] If on conventional PAH medication, including but not restricted to, calcium channel blockers, diuretics, digoxin, and oxygen therapy, the patient must be on stable doses with no changes (other than weight-based adjustments) for at least 4 weeks before screening.
- •[7] Have a chest radiograph (CXR) within 6 months of screening that shows clear lung fields or no more than mild patchy (not diffuse) interstitial infiltrates.
- •[8] Female patients of childbearing potential must test negative for pregnancy during screening. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by the investigator during the study.
- •Examples of reliable birth control methods include abstinence; the use of oral contraceptives; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices).
- •[9] Written informed consent from parents or guardians (and written assent from appropriately aged patients) will be obtained prior to any study procedure being performed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •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
- •Patients are not eligible to be included in the study if they meet any of the following exclusion criteria:
- •[10] Have pulmonary hypertension related to conditions other than specified above, including but not limited to chronic thromboembolic disease, portal pulmonary hypertension, leftsided heart disease or lung disease and hypoxia.
- •[11] History of left-sided heart disease, including any of the following:
- •- clinically significant (pulmonary artery occlusion pressure [PAOP] 15 to
- •18 mm Hg) aortic or mitral valve disease (that is, aortic stenosis, aortic
- •insufficiency, mitral stenosis, moderate or greater mitral regurgitation);
- •- pericardial constriction;
- •- restrictive or congestive cardiomyopathy;
- •- left ventricular ejection fraction <40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography;
- •- left ventricular shortening fraction <22% by echocardiography;
- •- life-threatening cardiac arrhythmias;
- •- symptomatic coronary artery disease within 5 years of study entry as determined by the physician.
- •[12] History of atrial septostomy or Potts Shunt within 3 months before administration of study drug.
- •[13] Unrepaired congenital heart disease except associated with an atrial-ventricular septal defect.
- •[14] Concurrent PDE-5 inhibitor therapy (sildenafil or vardenafil) or has received PDE-5 inhibitor therapy within 24 hours prior to the first study drug dosing (baseline visit).
- •[15] Concurrent therapy with prostacyclin or its analogues.
- •[16] Commence or discontinue a conventional PAH medication including but not restricted to: calcium channel blockers, diuretics, anti-coagulants, digoxin, and oxygen therapy within 4 weeks prior to screening.
- •[17] Have a history of angina pectoris or other condition that was treated with long- or short acting nitrates within 12 weeks before administration of study drug.
- •[18] Currently receiving treatment with doxazosin, nitrates or cancer therapy.
- •[19] Current treatment with antiretroviral therapy (protease inhibitor), systemic ketoconazole or systemic itraconazole.
- •[20] Are nursing or pregnant.
- •[21] Have a WHO functional class value of IV at the time of enrollment.
- •[22] Have severe hepatic cirrhosis, Child-Pugh Grade C.
- •[23] Have severe renal insufficiency, defined as receiving renal dialysis or having a measured or estimated creatinine clearance (CC) < 30 mL/min (Schwartz Formula):
- •All Females and Pre-adolescent Males:
- •Ccr (mL/min/1.73 m2) = 0.55 × Height (cm) / SCr (mg/dL)
- •Adolescent Males:
- •Ccr (mL/min/1.73 m2) = 0.70 × Height (cm) / SCr (mg/dL)
- •Where Ccr is Creatinine Clearance and SCr is Serum Creatinine
- •[24] Have severe hypotension or uncontrolled hypertension as determined by the Investigator.
- •[25] Diagnosed with a retinal disorder (for example, hereditary retinal disorders, retinopathy of the preterm and other retinal disorders)
- •[26] Have significant parenchymal lung disease.
- •[27] Have bronchopulmonary dysplasia.
- •[28] Have hemoglobinopathies.
- •[29] Have a history of drug, alcohol, or substance abuse within the past 6 months or present use, as assessed by the investigator.
- •[30] Have previously completed or withdrawn from this study (Study LVIG), or any other study investigating tadalafil.
- •[31] Have previously taken tadalafil or are hypersensitive to tadalafil.
- •[32] Unable to take orally administered tablet (without chewing, crushing or breaking) or liquid suspension.
- •[33] Investigator site personnel (or their immediate family) directly affiliated with this study. Immediate family i
研究者
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