A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:2/7/2019
Start Date:July 17, 2012
End Date:May 17, 2019

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A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension

The purpose of this study is to see how much study drug is in the blood of children with
pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further
clinical research.

During Period I, tadalafil will be administered orally, once daily, at a low dose for
approximately 5 weeks followed by a high dose for approximately 5 weeks. Dose levels are
calculated based on body weight cohorts. Heavy weight cohort >=40 kg, middle weight cohort
>=25 kg to <40 kg. Light weight cohort<25 kg. Participants who complete Period 1 may continue
taking tadalafil in Period 2 for at least 2 years. Starting dose will not exceed the maximum
weight range dose established in Period 1 and after the first 3 months of Period 2, the dose
may be adjusted based on available safety and efficacy information.

Inclusion Criteria:

- 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).

- 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, participants 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

- Have a World Health Organization (WHO) functional class value of I, II or III at the
time of enrollment

Exclusion Criteria:

- Have pulmonary hypertension related to conditions other than specified above,
including but not limited to chronic thromboembolic disease, portal pulmonary
hypertension, left-sided heart disease or lung disease and hypoxia

- 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

- History of atrial septostomy or Potts Shunt within 3 months before administration of
study drug

- Unrepaired congenital heart disease
We found this trial at
6
sites
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Curt Daniels
Phone: 614-355-3450
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Brian Hanna
Phone: 215-590-2711
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Atlanta, Georgia 30322
Principal Investigator: Usama Kanaan
Phone: 404-785-0040
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Jeffrey Darst
Phone: 720-777-5379
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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