Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension PAH treprostinil sodium inhalation ventavis iloprost
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 73
Healthy volunteers: no

Brief summary:
This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).

Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.

Detailed description:

Arms:
arm 1: Solution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily.

Interventions: intervention 1: Inhaled treprostinil
Intervention descriptions: intervention 1: None

Protocol document: