Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02999906
Status:
WITHDRAWN
Last Update Posted:
2017-11-01
First Post:
2016-12-19
Brief Title:
Study to Compare Triple Therapy Oral Treprostinil Ambrisentan and Tadalafil With Dual Therapy Ambrisentan Tadalafil and Placebo in Subjects With Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Study to Compare the Efficacy and Safety of Triple Therapy Oral Treprostinil Ambrisentan and Tadalafil With Dual Therapy Ambrisentan Tadalafil and Placebo in Subjects With Pulmonary Arterial Hypertension
Status:
WITHDRAWN
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
For business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized 21 oral treprostinil placebo double-blind placebo-controlled study in subjects with Pulmonary Arterial Hypertension PAH who are currently receiving background dual therapy ambrisentan tadalafil for at least 30 days at randomization for their PAH Once randomized subjects will return for 5 study visits up to Week 28 during the blinded period After the Week 28 Visit eligible subjects will transition to the open-label period of the study for up to 20 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None