NCT01824290

A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Tadalafil	Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.
DRUG	Placebo	Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.
DRUG	ERA as specific PAH treatment	All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).

Timeline

• Start date: 2014-02-05
• Primary completion: 2019-03-18
• Completion: 2021-03-10
• First posted: 2013-04-04
• Last updated: 2021-11-05
• Results posted: 2020-03-23

Locations

43 sites across 14 countries: United States, Austria, Belgium, Brazil, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Spain, Turkey (Türkiye)