NCT02603068

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Multicenter, Randomized, Open Label Trial to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.

Detailed description

This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.

Conditions

• Pulmonary Hypertension
• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Oral treprostinil	Oral treprostinil will be administered as TID dosing for up to 16 Weeks.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-04-01
• Completion: 2018-07-01
• First posted: 2015-11-11
• Last updated: 2016-02-09

Locations

7 sites across 1 country: United States