Tadalafil

Articles · Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·

407734006

Articles

Medicine Compliance Aid Stability

Adcirca · Eli Lilly and Co Ltd

Eli Lilly and Co Ltd
Adcirca
Tablets f/c 20mg
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Unsuitable
9th November 2015

Lactation Safety Information

for pulmonary hypertension

for pulmonary hypertension
Sildenafil
No published evidence of safety
16th January 2017

New Medicines

Adcirca · Pulmonary hypertension in children

Information

Adcirca
Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Phosphodiesterase inhibitor
In its pure idiopathic form it is a rare disease with an approximate annual incidence of about 1–3 cases per million population.2 There is a higher incidence of cases associated with connective tissue disease – about 10% of sufferers of CREST/scleroderma syndromes have the condition.
Pulmonary hypertension in children
Oral

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 [5]


Jan 16. The phase III study is still recruiting subjects, with an planned final data collection date for primary outcome measure of Dec 2016 [4].


Mar 15: PIII (NCT01824290) study is ongoing and recruiting pts [3].


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) [1].