ADAPT - a Patient Registry of the Real-world Use of Orenitram®

United Therapeutics41 sites in 1 country300 target enrollmentJuly 18, 2017

ConditionsPulmonary Arterial Hypertension

InterventionsOral treprostinil

Overview

Phase: N/A
Intervention: Oral treprostinil
Conditions: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Enrollment: 300
Locations: 41
Primary Endpoint: Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation

Registry

clinicaltrials.gov

Start Date

July 18, 2017

End Date

December 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

United Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Oral treprostinil

Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients

Intervention: Oral treprostinil

Outcomes

Primary Outcomes

Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients

Time Frame: Baseline to Week 78

Secondary Outcomes

To assess treatment-related outcomes during routine clinical care.(Baseline to Week 78)
To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies(Baseline to Week 78)
Health-related quality of life in PAH and treatment satisfaction(Baseline to Week 78)
To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest(Baseline to Week 78)
Healthcare resource utilization trends(Baseline to Week 78)
To evaluate reasons for discontinuation of Orenitram(Baseline to Week 78)
To evaluate titration and dosing schedules of Orenitram(Baseline to Week 78)
Use of concomitant medications(Baseline to Week 78)