A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)

H6D-MC-LVHV -

The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.

Trial Summary

Age Range
6 months - 17 years
Conditions the trial is for
Pulmonary Arterial Hypertension
What the trial is testing?
Tadalafil
Could I receive a Placebo?
Yes
Enrollment Goal
35
Trial Dates
Feb 5, 2014 - Mar 10, 2021
How long will I be in the trial?
Your participation could last up to 2.5 years and include 17 visits to the study center.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have a diagnosis of PAH that is either idiopathic (including hereditary), related to connective tissue disease, related to anorexigen use, or associated with surgical repair of at least 6-month duration of congenital systemic to pulmonary shunt

  • Participant must be receiving an endothelin receptor antagonist (ERA) (such as bosentan or ambrisentan) and must be on a maintenance dose with no change in dose (other than weight-based adjustments) for at least 12 weeks prior to the start of the study

  • Participant on conventional PAH medication, including but not restricted to, anticoagulants, diuretics, digoxin, and oxygen therapy, must be on stable doses with no changes (other than weight-based adjustments) for at least 4 weeks before screening for the study

  • Female participant of childbearing potential must test negative for pregnancy during screening. Female participant must also agree to abstain from sexual activity or to use two different reliable methods of birth control

Participants Must Not:

  • Participant must not have any other type of pulmonary hypertension, history of left-sided heart disease, or severe liver impairment, Child-Pugh Grade C

  • Participant must not have been diagnosed with a retinal disorder (eg, hereditary retinal disorders, retinopathy of the preterm participant and other retinal disorders)

  • Participant must not have a diagnosis of Down syndrome

  • Participant must not be receiving current treatment with potent Cytochrome P450 3A4 (CYP3A4) inhibitors, such as antiretroviral therapy (protease inhibitor), systemic ketoconazole, or systemic itraconazole, or chronic use of potent CYP3A4 inducers, such as rifampicin

  • Participant must not have previously completed or withdrawn from this study (LVHV), or any other study investigating tadalafil

  • Female participant must not be pregnant or breastfeeding

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