A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension

Status: Completed

Phase of Trial: Phase I/II

Latest Information Update: 17 Aug 2021

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At a glance

11 Aug 2021 Results of pooled adult/pediatric population analysis assessing pharmacokinetics of tadalafil to explored in a pediatric phase Ib/II (NCT01484431; n=19) study and pooled with prior phase III (pulmonary arterial hypertension and response to tadalafil [PHIRST-1; NCT00125918; n=305]) adult data to develop the first population PK model for tadalafil in pediatric patients with pulmonary arterial hypertension, published in the Clinical Pharmacokinetics.
20 Jun 2019 Results published in the British Journal of Clinical Pharmacology
11 Apr 2019 Status changed from active, no longer recruiting to completed.

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