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Clinical Trials/EUCTR2011-001873-24-PL
EUCTR2011-001873-24-PLActive, not recruitingPhase 1

A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension

Eli Lilly and Company0 sites24 target enrollmentStarted: December 9, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
24
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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 (including hereditary),
  • •- related to collagen vascular disease,
  • •- related to anorexigen use,
  • •- associated with surgical repair, of at least 6 month duration, of a
  • •congenital systemic-to pulmonary shunt (for example, atrial septal
  • •defect, 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. 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] Patients with PAH either naïve to PAH specific therapy or receiving endothelin receptor antagonists (ERA). 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 true abstinence as a lifestyle choice (periodic sexual abstinence method is not acceptable); 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

Exclusion Criteria

  • •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 Potts Shunt within 3 months before administration of study drug.
  • •[13] Unrepaired congenital heart disease.
  • •[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 potent CYP3A4 inhibitors, such as
  • •antiretroviral therapy (protease inhibitor), systemic ketoconazole or
  • •systemic itraconazole, or chronic use of potent CYP3A4 inducers, such as
  • •rifampicin.
  • •[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 within 90 days prior to the first
  • •study drug dosing (Day 1, Visit 2) or are hypersensitive to tadalafil.
  • •[32] Unable to take orally administered tablet (without chewing, crushing or breaking) or liquid su

Investigators

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