drugset / Trial / NCT01824290
A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.
Timeline
- Start
- 2014-02-05
- Primary completion
- 2019-03-18
- Completion
- 2021-03-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tadalafil | Small molecule | 20 mg | Oral |
| Subject | Tadalafil | Small molecule | 40 mg | Oral |
| Background | Ambrisentan | Small molecule | — | — |
| Background | Bosentan | Other / unclassified | — | — |
| Background | Macitentan | Other / unclassified | — | — |