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NCT04039464 · ClinicalTrials.gov registry record · Phase 3
Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT04039464: Completed Phase 3 study, sponsored by Johns Hopkins University.
NCT04039464 is a Phase 3 study that has completed, run by Johns Hopkins University. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04039464, a Phase 3 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study Summary
The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.
Primary Outcome
There are four WHO functional classes: Class I: Pulmonary hypertension without resulting limitation of physical activity; Ordinary physical activity does not cause undue dyspnea or fatigue, or chest pain or near-syncope; Class II: Pulmonary hypertension resulting in a slight limitation of physical activity; Comfortable at rest; Ordinary physical activity causes undue dyspnea or fatigue, or chest pain or near-syncope; Class III: Pulmonary hypertension resulting in a marked limitation of physical
Interventions
- DRUG Mono-Therapy with Sildenafil
- DRUG Duo-Therapy with Sildenafil + Bosentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the finished NCT04039464 record still lists
NCT04039464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Mono-Therapy with Sildenafil is the first listed.
NCT04039464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04039464 about?
NCT04039464 is a clinical study titled "Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension". The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initi...
What is the current status of trial NCT04039464?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2022-08-01. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT04039464?
The interventions under investigation include: Mono-Therapy with Sildenafil (DRUG), Duo-Therapy with Sildenafil + Bosentan (DRUG).
Who is sponsoring clinical trial NCT04039464?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04039464's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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