NCT00147199

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Inhaled treprostinil	Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.
DRUG	Placebo inhalation solution	Doses are titrated to 9 breaths four times daily.

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-09-07
• Last updated: 2024-01-02
• Results posted: 2013-08-12

Locations

30 sites across 10 countries: United States, Austria, Belgium, France, Germany, Ireland, Israel, Italy, Spain, United Kingdom