Pulmonary Arterial Hypertension
Conditions
Brief summary
To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.
Interventions
0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.
DRUGPlacebo
placebo inhalation solution
Sponsors
United Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Eligible subjects must: * Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed), * Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use. * Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening. * Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-minute walk test | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to clinical worsening | 1 day to 2.5 years. |
Outcome results
None listed