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

Active, not recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Oral treprostinil

• Registration Number: NCT03045029
• Lead Sponsor: United Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Study Start: 2017-07-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral treprostinil	Oral treprostinil	Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients

Primary Outcome Measures

Name	Time	Method
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients	Baseline to Week 78

Secondary Outcome Measures

Name	Time	Method
To assess treatment-related outcomes during routine clinical care.	Baseline to Week 78	eg, 6-Minute Walk Distance \[6MWD\], World Health Organization \[WHO\] Functional Class \[FC\]
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

Trial Locations

Locations (41)

University of California - San Francisco; 🇺🇸 Fresno, California, United States

University of Southern California - Keck Medical Center; 🇺🇸 Los Angeles, California, United States

Paloma Medical Group; 🇺🇸 San Juan Capistrano, California, United States

Santa Barbara Pulmonary Associates; 🇺🇸 Santa Barbara, California, United States

Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States

Aurora Denver Cardiology Associates; 🇺🇸 Aurora, Colorado, United States

Pueblo Pulmonary Associates; 🇺🇸 Pueblo, Colorado, United States

Lung Associates PA; 🇺🇸 Bradenton, Florida, United States

University of Florida Clinical Research Center; 🇺🇸 Gainesville, Florida, United States

St. Vincent's Lung, Sleep, and Critical Care Specialists; 🇺🇸 Jacksonville, Florida, United States

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