Medicine Compliance Aid Stability
Adcirca · Eli Lilly and Co Ltd
Lactation Safety Information
for pulmonary hypertension
Adcirca · Pulmonary hypertension in children
Development and Regulatory status
Trial or other data
Dec 18. The phase III study is still recruiting subjects, with an planned final data collection date for primary outcome measure of Jan 2021 
Jan 16. The phase III study is still recruiting subjects, with an planned final data collection date for primary outcome measure of Dec 2016 .
Mar 15: PIII (NCT01824290) study is ongoing and recruiting pts .
Apr 13: NCT01824290 is a PIII study of tadalafil in 134 paediatric patients (≥6 months to <18 years of age at screening) with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and be eligible to enrol into an open-label 2 year extension period (Period 2) during which all participants will receive tadalafil. At screening all participants must be receiving an endothelin receptor antagonist (bosentan or ambrisentan) and must be on a maintenance dose with no change in dose (other than weight-based adjustments) for at least 12 weeks, and have an AST/ALT <3 times the upper limit of normal. The primary outcome is change from baseline to week 24 in a 6 minute walk distance in metres. The study starts Apr 13 and is due to complete Sep 2022 (primary outcome data Dec 16) .