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A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Summary

The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.

Clinical Trial Description

During Period I, tadalafil will be administered orally, once daily, at a low dose for approximately 5 weeks followed by a high dose for approximately 5 weeks. Dose levels are calculated based on body weight cohorts. Heavy weight cohort >=40 kg, middle weight cohort >=25 kg to <40 kg. Light weight cohort<25 kg. Participants who complete Period 1 may continue taking tadalafil in Period 2 for at least 2 years. Starting dose will not exceed the maximum weight range dose established in Period 1 and after the first 3 months of Period 2, the dose may be adjusted based on available safety and efficacy information. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01484431
Study type Interventional
Source Eli Lilly and Company
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 17, 2012
Completion date April 3, 2019
View Details
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