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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT00147199
• Date of registration: 02/09/2005
• Prospective Registration: No
• Primary sponsor: United Therapeutics
• Public title: Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) TRIUMPH
• Scientific 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
• Date of first enrolment: June 2005
• Target sample size: 235
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00147199
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, France, Germany, Ireland, Israel, Italy, Spain, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinically stable, pulmonary arterial hypertension diagnosed as either idiopathic or
familial PAH, collagen vascular disease associated PAH, HIV PAH, or PAH induced by
anorexigens, New York Heart Association (NYHA) Class III or Class IV.

- 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

- An unencouraged six minute walk test (6MWT) of between 200 and 450 meters at screening

- Cardiac catheterization within the past 13 months consistent with PAH, specifically
mean pulmonary artery pressure (PAPm) =25 mmHg (at rest), pulmonary capillary wedge
pressure (PCWP) (or left ventricular end diastolic pressure) =15 mmHg, and pulmonary
vascular resistance (PVR) >3 mmHg/L/min

- Within the past 12 months, patients must have had a chest radiograph consistent with
the diagnosis of PAH

- Willing and able to follow all study procedures

Exclusion Criteria:

- Considering pregnancy, are pregnant and/or lactating

- PAH due to conditions other than noted in the above inclusion criteria.

- Have had any change in or discontinued any PAH medication within the last three
months, including but not limited to endothelin receptor antagonist (ERA), or calcium
channel blockers (CCB) (with the exception of anticoagulants)

- Have received any prostanoid within the 30 days before screening or are scheduled to
receive any during the course of the study

- Have received any investigational medication within 30 days prior to the start of this
study or are scheduled to receive another investigational drug during the course of
this study

- Have a known intolerance to any drug, especially to treprostinil sodium or prostanoids

- Have an increased risk of hemorrhage

- Have a new type of chronic therapy (e.g., a different category of vasodilator,
diuretic) for PAH added within the last month, except anticoagulants

- Have any musculoskeletal disease or any other disease that would limit ambulation.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Placebo inhalation solution

Drug: Inhaled treprostinil

Primary Outcome(s)

Peak 6-minute Walk Distance [Time Frame: 12 weeks]

Secondary Outcome(s)

Change in Signs and Symptoms of PAH [Time Frame: 12 weeks]

Borg Dyspnea Score [Time Frame: 12 weeks]

Peak 6MWD at Week 6 [Time Frame: 6 weeks]

N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP) [Time Frame: 12 weeks]

New York Heart Association (NYHA) Functional Classification [Time Frame: 12 weeks]

Quality of Life (Minnesota Living With Heart Failure) [Time Frame: 12 weeks]

Trough 6MWD at Week 12 [Time Frame: 12 Weeks]

Clinical Worsening Events [Time Frame: 12 weeks]

Secondary ID(s)

LRX-TRIUMPH 001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/08/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00147199