drugset / Trial / NCT04039464
Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
Phase 3
Completed
28 enrolled
Johns Hopkins University
National Center for Advancing Translational Sciences (NCATS) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2022-08-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bosentan | Other / unclassified | — | Oral |
| Comparator | Sildenafil | Unknown | — | Oral |