At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
In Brief
A Phase 4 clinical trial evaluating Remodulin for Pulmonary Arterial Hypertension. Completed, enrolled 39 participants.
Detailed Summary
The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration regimen of subcutaneous Remodulin® therapy in patients with PAH.
Study Details
Timeline
Interventions
Treatment will be initiated whilst hospitalized at approximately 2.0 ng/kg/min with dose increments of 1- 2 ng/kg/min approximately every 12 hours according to clinical response and tolerability. Following subject discharge, the dose rate is increased by 1-2 ng/kg/min with dose increments separated by at least 24 hours. When a dose rate of 20 ng/kg/min is achieved dose increments can be increased at a rate of up to 4 ng/kg/min with dose increments separated by at least 24 hours depending on tolerability. The aim is to achieve a dose rate of at least 10, 20 and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively and a dose rate by the end of week 16 that achieves pre-defined treatment goals subject to clinical response and tolerability.