Title of Study:
TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
Description:
Primary Outcomes: 6-minute walk distance, change from baseline to Week 12
Secondary Outcomes: NYHA functional classification; Borg dyspnea scoring; Signs and symptoms of PAH; Quality of life; Time to clinical worsening, first incidence of clinical worsening
Expected Total Enrollment: 200
Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan OR a stable dose of sildenafil for at least three months prior to study start will be randomized to either Treprostinil inhalation solution or matching placebo.
Administration of study medication will be performed by inhalation with the OPTINEB™ ultrasonic nebulizer.
The proposed dosing regimen will be four times daily—upon awakening, at midday, evening (dinner time) and bedtime.
After a patient has completed the twelve-week study period, they will be given the option of enrolling into an open-label extension study.
Contact:
Email: clinicaltrials@lungrx.com
Website for more information
Study Sponsor:
Lung Rx, Inc.
