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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04039464
The ClinicalTrials.gov registry entry for NCT04039464 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mono-Therapy with Sildenafil is the first listed.
NCT04039464 reports 0 study locations.
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.
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