At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 235 enrolled
Drug / intervention
Inhaled treprostinil +1 moredrug
Likely dose
Inhaled treprostinil 9 breaths four times daily (18 mcg per breath, ~648 mcg total daily)AI-extracted
Key inclusion· 6
- ✓Clinically stable pulmonary arterial hypertension: idiopathic, familial, collagen vascular disease-associated, HIV-associated, or anorexigen-induced PAH
- ✓NYHA Class III or IV functional status
- ✓On stable background therapy: bosentan 125 mg twice daily OR any stable dose of sildenafil for ≥3 months
- ✓6-minute walk test 200-450 meters at screening
Key exclusion· 9
- ✕Pregnant, planning pregnancy, or lactating
- ✕PAH from etiologies other than idiopathic, familial, collagen vascular disease, HIV, or anorexigen-induced
- ✕Any change in or discontinuation of PAH medication within last 3 months (except anticoagulants)
- ✕Any prostanoid use within 30 days before screening or scheduled during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
In Brief
A Phase 3 clinical trial evaluating Inhaled treprostinil and Placebo inhalation solution for Pulmonary Hypertension. Completed, enrolled 235 participants across 30 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesAustria, Belgium, France, Germany, Ireland, Israel, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedSep 2005
Primary CompletionOct 2007
TodayJul 2026
First PostedSep 7, 2005
Enrollment StartJun 1, 2005
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.8 years ago
Interventions
Inhaled treprostinildrug
Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.
Placebo inhalation solutiondrug
Doses are titrated to 9 breaths four times daily.