Completed

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

H6D-MC-LVHV - ClinicalTrials.gov - NCT01824290

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.
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
Email
Completed

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

H6D-MC-LVHV - ClinicalTrials.gov - NCT01824290

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.
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
Email

Key Requirements

Age :

< 18

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

< 18

Sex

All

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

Trial Summary

Conditions the trial is for

Pediatric Pulmonary Arterial Hypertension

What the trial is testing?

Tadalafil (LY450190), Placebo

Could I receive a Placebo?

yes

Enrollment Goal

34

Trial Dates

February 2014 - March 2021

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

< 18

Sex

All

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

Trial Summary

Conditions the trial is for

Pediatric Pulmonary Arterial Hypertension

What the trial is testing?

Tadalafil (LY450190), Placebo

Could I receive a Placebo?

yes

Enrollment Goal

34

Trial Dates

February 2014 - March 2021

Trial Phase

3

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Trial Locations

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Pediatric Pulmonary Arterial Hypertension Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?