Clinical Trial: Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension
Brief Summary: This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.
Detailed Summary:
Sponsor: United Therapeutics
Current Primary Outcome: Incidence of Adverse Events (AEs) through 16 Weeks [ Time Frame: 16 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
- Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
- Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
- Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
- Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
Original Secondary Outcome: Same as current
Information By: United Therapeutics
Dates:
Date Received: January 6, 2017
Date Started: May 2017
Date Completion: September 2018
Last Updated: April 7, 2017
Last Verified: April 2017
