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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
MoD 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.Check my eligibility
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.See study design
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.
MoD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 months and 18 years old.
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My child has not been on long-term PAH medication.
Select...
I have been diagnosed with pulmonary arterial hypertension.
Select...
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.
MoD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in WHO functional class (FC) of Mono vs. Dual Therapy
Secondary outcome measures
Time to clinical worsening (TTCW)
MoD 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
2,266 Previous Clinical Trials
14,837,397 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,554 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
322 Previous Clinical Trials
401,663 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 3 months and 18 years old.My child has not been on long-term PAH medication.I have been diagnosed with pulmonary arterial hypertension.My pulmonary hypertension is not caused by specific heart conditions.My heart function is moderately affected.I am not taking cyclosporine A, glyburide, CYP3A inhibitors, or beta blockers, and I did not have congenital heart disease surgery in the last 6 months.My child, over 1 year old, has a specific type of high blood pressure in the lungs and responds well to certain tests.You have recently abused alcohol or illegal drugs.You had a heart test called cardiac catheterization in the last six months and it showed specific heart function results.My infant is under one year old and meets certain heart ultrasound criteria.I have certain heart and lung conditions.Your test results at the screening visit are not within the normal range.I cannot take pills as directed.I have experienced specific symptoms in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy with Sildenafil Group
- Group 2: Duo Therapy with Sildenafil + Bosentan Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could elderly patients benefit from this clinical trial's findings?
"This study includes children that are a minimum of 4 months old, and 18 years old at most."
Answered by AI
By how many staff members is this clinical trial managed?
"According to the study's website, patients can be enrolled at Johns Hopkins University, Children's Hospital of Philadelphia, Stollery Children's Hospital, and 13 other locations."
Answered by AI
Do we have precedent for the success of this proposed treatment plan?
"The first study investigating the efficacy of duo therapy with sildenafil and bosentan was completed in 2011 at the Academic Medical Center. As of now, a total of 228 studies have been completed with 34 live studies. A large concentration of these studies are based in Baltimore, Maryland."
Answered by AI
What are the risks associated with Sildenafil + Bosentan Group Duo Therapy?
"This treatment, which is a combination of sildenafil and bosentan, is considered to be safe based on data from previous clinical trials."
Answered by AI
To what patient population is this research study open?
"This trial is seeking around 100 children from 4 months to 18 years old that have pulmonary arterial hypertension."
Answered by AI
What condition does the medical treatment of Duo Therapy with Sildenafil + Bosentan Group help patients with?
"While commonly used to treat premature ejaculation, duo therapy with Sildenafil + Bosentan can also help patients manage pulmonary arterial hypertension, ocular inflammation, and other conditions."
Answered by AI
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