Trial intelligence / Profile preview

Tadalafil in pediatric pulmonary arterial hypertension

NCT01824290Phase 3

Key facts

Status: Completed
Start: Feb 2014
Primary completion: Mar 2019
Countries: 14
Sponsor: Eli Lilly and Company
Modality: Small Molecules

Drugs: tadalafil
Conditions: pulmonary arterial hypertension (PAH)

Overview

Phase 3, randomised, double-blind trial in pulmonary arterial hypertension (PAH) comparing Tadalafil with Placebo (2 arms). Primary endpoint: Change From Baseline to Week 24 in a 6 Minute Walk Distance. Started Feb 2014; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Tadalafil
Tadalafil + ERA
Placebo
Placebo + ERA

Who it enrols

Pediatric patients (6 months to <18 years) with PAH (idiopathic, hereditary, CTD-related, anorexigen-related, or congenital heart defect repair) on stable ERA therapy.

Endpoints

Primary

Change From Baseline to Week 24 in a 6 Minute Walk Distance24 weeks

Secondary

Time to Adjudicated Clinical Worsening24 weeks
Percentage of Participants Who Experience Clinical Worsening24 weeks
Apparent Clearance (CL/F) of Tadalafil at Steady-state24 weeks

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