Clinical Trial: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]
Official Title: ADAPT - A Patient Registry of the Real-world Use of Orenitram®
Brief Summary: This is a prospective, observational, multicenter, patient registry to observe and assess the real-world use and tolerability of Orenitram (treprostinil). Patients who are newly initiated on Orenitram for the treatment of pulmonary arterial hypertension (PAH) or who transition from another prostacyclin therapy will be evaluated for 52 weeks to observe dosing regimens, titration schedules, prostacyclin-related adverse events (AEs), and clinical outcomes of interest.
Detailed Summary:
Sponsor: United Therapeutics
Current Primary Outcome: Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients [ Time Frame: Baseline to Week 52 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Treatment-related outcomes collected by study sites during routine clinical care [ Time Frame: Baseline to Week 52 ]
- Development, timing, severity, and frequency of prostacyclin-related AEs [ Time Frame: Enrollment to Week 52 ]
- Use of concomitant medications [ Time Frame: Baseline to Week 52 ]
- Reasons for discontinuing Orenitram and information on clinical titration schedules implemented for transition to alternative prostacyclin therapies [ Time Frame: Enrollment to Week 52 ]
- Healthcare resource utilization trends [ Time Frame: Baseline to Week 52 ]
- Health-related quality of life in PAH and treatment satisfaction [ Time Frame: Baseline to Week 52 ]
Original Secondary Outcome: Same as current
Information By: United Therapeutics
Dates:
Date Received: February 2, 2017
Date Started: June 2017
Date Completion: June 2019
Last Updated: April 20, 2017
Last Verified: February 2017
