At a glance
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A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension
In Brief
A Phase 3 clinical trial evaluating Tadalafil, Placebo, and 1 other intervention for Hypertension, Pulmonary. Completed, enrolled 35 participants across 43 sites in 14 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.
Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.
All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).