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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01484431 |
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Date of registration:
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30/11/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
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Scientific title:
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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 |
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Date of first enrolment:
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July 17, 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01484431 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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France
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Poland
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Tadalafil- Tablet or Oral suspension
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Primary Outcome(s)
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Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil
[Time Frame: Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49]
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Population Pharmacokinetics: Average Concentration (Cmean,ss) of for Tadalafil at Steady-State.
[Time Frame: Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49]
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Secondary Outcome(s)
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Number of Participants With Palatability of the Tadalafil Suspension
[Time Frame: Day 35 (high dose)]
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Percentage of Participants With Clinical Worsening
[Time Frame: Baseline Up to 27 Months]
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Secondary ID(s)
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12917
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H6D-MC-LVIG
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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