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Phosphodiesterase-5 (PDE-5) Inhibitor

Mono vs Dual Therapy for Pediatric Pulmonary Hypertension (MoD Trial)

Phase 3
Recruiting
Led By Lewis Romer, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥3 months to < 18 years
Children who have not been treated with long-term targeted PAH drug therapy, including calcium channel blockers (CCB), prostanoids, endothelin receptor antagonists (ERA), or PDE-5 inhibitors (PDE5i)
Must not have
Evidence of specific cardiac and pulmonary conditions
Inability to take oral medications as prescribed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if a combination of two drugs is better than just one drug at treating PAH in children.

Who is the study for?
This trial is for children aged 3 months to under 18 years with a diagnosis of pediatric pulmonary arterial hypertension, who haven't used long-term PAH drugs. They should be in WHO functional class II or III and able to take oral medications. Kids with certain heart diseases, drug abuse history, noncompliance issues, or on conflicting medications can't join.
What is being tested?
The study tests if using two drugs (Sildenafil + Bosentan) together works better than just one (Sildenafil alone) for improving health status in kids with pulmonary hypertension after one year of treatment. It's checking the effectiveness of early combination therapy versus monotherapy.
What are the potential side effects?
Possible side effects include headaches, flushing, nosebleeds, upset stomachs, and sleep problems from Sildenafil; liver function changes and anemia from Bosentan. Each child may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 months and 18 years old.
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My child has not been on long-term PAH medication.
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I have been diagnosed with pulmonary arterial hypertension.
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My pulmonary hypertension is not caused by specific heart conditions.
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My heart function is moderately affected.
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My infant is under one year old and meets certain heart ultrasound criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have certain heart and lung conditions.
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I cannot take pills as directed.
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I have experienced specific symptoms in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in WHO functional class (FC) of Mono vs. Dual Therapy
Secondary study objectives
Time to clinical worsening (TTCW)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Monotherapy with Sildenafil GroupActive Control1 Intervention
mono-therapy: first-line monotherapy (sildenafil alone) - in pediatric subjects with PAH.
Group II: Duo Therapy with Sildenafil + Bosentan GroupActive Control1 Intervention
duo-therapy: compare two treatment strategies - first-line combination therapy (sildenafil and bosentan)

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,874,200 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,929 Previous Clinical Trials
47,765,127 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
362 Previous Clinical Trials
412,384 Total Patients Enrolled

Media Library

Sildenafil (Phosphodiesterase-5 (PDE-5) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04039464 — Phase 3
Pediatric Pulmonary Hypertension Research Study Groups: Monotherapy with Sildenafil Group, Duo Therapy with Sildenafil + Bosentan Group
Pediatric Pulmonary Hypertension Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT04039464 — Phase 3
Sildenafil (Phosphodiesterase-5 (PDE-5) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04039464 — Phase 3
~45 spots leftby Sep 2026
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