Treprostinil

Status
Phase 2
Condition
Pulmonary Hypertension
Intervention Type
Inhaled Drug
Funder Type
Industry

Drug Details

Inhaled treprostinil is an inhaled medication approved for the treatment of pulmonary arterial hypertension in World Health Organization (WHO) Group 1 patients. Inhaled treprostinil is a synthetic analogue of prostacyclin, a naturally occurring substance in the body, which has effects on dilating blood vessels. Inhaled treprostenil was approved for PAH by the United States Food and Drug Administration (FDA) in 2009. 

Study Purpose

This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

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