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

Pulmonary Arterial Hypertension Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03045029
• Other study ID #: TDE-PH-401
• Status: Active, not recruiting
• Start date: July 18, 2017
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

Patients are eligible for the registry if:

1. The patient voluntarily gives informed consent to participate in the study.

2. The patient must be at least 18 years of age or older.

3. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days.

4. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study.

5. The patient has the ability to answer surveys and use the diary in English.

6. The patient must have an email address and be willing to access the PRO Portal.

EXCLUSION CRITERIA

Patients are ineligible for the registry if:

1. The patient has previously received Orenitram for more than 182 days.

2. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within

Related Conditions & MeSH terms

• Pulmonary Arterial Hypertension

Intervention

Drug:
• Oral treprostinil
Sustained-release oral tablets for TID administration

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	AnMed Health Pulmonary and Sleep Medicine	Anderson	South Carolina
United States	Aurora Denver Cardiology Associates	Aurora	Colorado
United States	Piedmont Healthcare/Research	Austell	Georgia
United States	Lung Associates PA	Bradenton	Florida
United States	New York Methodist Hospital	Brooklyn	New York
United States	Loyola University Chicago	Chicago	Illinois
United States	Baylor University Medical Center	Dallas	Texas
United States	Pulmonary Health Physicians, PC	Fayetteville	New York
United States	University of California - San Francisco	Fresno	California
United States	University of Florida Clinical Research Center	Gainesville	Florida
United States	Houston Methodist Research Institute	Houston	Texas
United States	Saint Vincent Hospital and Health Services	Indianapolis	Indiana
United States	University Of Iowa Hospital and Clinics	Iowa City	Iowa
United States	Stony Brook University Medical Center	Islandia	New York
United States	St. Vincent's Lung, Sleep, and Critical Care Specialists	Jacksonville	Florida
United States	Center for Biomedical Research	Knoxville	Tennessee
United States	Lima Memorial Hospital	Lima	Ohio
United States	University of Southern California - Keck Medical Center	Los Angeles	California
United States	University of Louisville Physicians Outpatient Center	Louisville	Kentucky
United States	Heart Care Associates, LLC	Milwaukee	Wisconsin
United States	Northwell Health- Long Island Jewish Forest Hills	New Hyde Park	New York
United States	Mclaren Greater Lansing	Okemos	Michigan
United States	INTEGRIS Nazih Zuhdi Transplant Institution	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	AdventHealth Orlando	Orlando	Florida
United States	Central Florida Pulmonary Group, P.A.	Orlando	Florida
United States	Pinehurst Medical Clinic, INC.	Pinehurst	North Carolina
United States	University of Pittsburgh - Heart and Vascular Medicine Institute	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University (OHSU)	Portland	Oregon
United States	Pueblo Pulmonary Associates	Pueblo	Colorado
United States	Carilion Clinic	Roanoke	Virginia
United States	University of Rochester	Rochester	New York
United States	Paloma Medical Group	San Juan Capistrano	California
United States	Santa Barbara Pulmonary Associates	Santa Barbara	California
United States	Chest Medicine Associates	South Portland	Maine
United States	USF South Florida Heart Health	Tampa	Florida
United States	Renovatio Clinical	The Woodlands	Texas
United States	Harbor UCLA Medical Center	Torrance	California
United States	Beaumont Hospital Troy	Troy	Michigan
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients		Baseline to Week 78
Secondary	To assess treatment-related outcomes during routine clinical care.	eg, 6-Minute Walk Distance [6MWD], World Health Organization [WHO] Functional Class [FC]	Baseline to Week 78
Secondary	To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest		Baseline to Week 78
Secondary	Use of concomitant medications		Baseline to Week 78
Secondary	To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies		Baseline to Week 78
Secondary	Healthcare resource utilization trends		Baseline to Week 78
Secondary	Health-related quality of life in PAH and treatment satisfaction		Baseline to Week 78
Secondary	To evaluate reasons for discontinuation of Orenitram		Baseline to Week 78
Secondary	To evaluate titration and dosing schedules of Orenitram		Baseline to Week 78