Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02603068
Status:
WITHDRAWN
Last Update Posted:
2016-02-09
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Sponsor:
United Therapeutics
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study design was inadequate and would not achieve study endpoints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: