Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (INTREPID)

United Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Inhaled treprostinil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01557647

RIN-PH-302

Details and patient eligibility

About

To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

inhaled treprostinil

Experimental group

Treatment:

Drug: Inhaled treprostinil

placebo

Placebo Comparator group

Treatment:

Drug: Placebo