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Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) — TRIUMPH  

Pulmonary Hypertension Clinical Trial

Official title:
TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension

Clinical Trial Summary

This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

Clinical Trial Description

Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable dose of sildenafil for at least three months prior to study start were randomized to either treprostinil inhalation solution or matching placebo. Administration of study medication was performed by inhalation with the OPTINEB™ ultrasonic nebulizer. The proposed dosing regimen was four times daily-upon awakening, at midday, evening (dinner time) and bedtime. After a patient has completed the twelve-week study period, they were given the option of enrolling into an open-label extension study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00147199
Study type Interventional
Source United Therapeutics
Contact
Status Completed
Phase Phase 3
Start date June 2005
Completion date October 2007
View Details
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