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

NCT ID: NCT03045029

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-18

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral treprostinil

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

Oral treprostinil

Intervention Type DRUG

Sustained-release oral tablets for TID administration

Interventions

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Oral treprostinil

Sustained-release oral tablets for TID administration

Intervention Type DRUG

Other Intervention Names

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Treprostinil diethanolamine Treprostinil diolamine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California - San Francisco

Fresno, California, United States

Site Status

University of Southern California - Keck Medical Center

Los Angeles, California, United States

Site Status

Paloma Medical Group

San Juan Capistrano, California, United States

Site Status

Santa Barbara Pulmonary Associates

Santa Barbara, California, United States

Site Status

Harbor UCLA Medical Center

Torrance, California, United States

Site Status

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

Site Status

Pueblo Pulmonary Associates

Pueblo, Colorado, United States

Site Status

Lung Associates PA

Bradenton, Florida, United States

Site Status

University of Florida Clinical Research Center

Gainesville, Florida, United States

Site Status

St. Vincent's Lung, Sleep, and Critical Care Specialists

Jacksonville, Florida, United States

Site Status

AdventHealth Orlando

Orlando, Florida, United States

Site Status

Central Florida Pulmonary Group, P.A.

Orlando, Florida, United States

Site Status

USF South Florida Heart Health

Tampa, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Piedmont Healthcare/Research

Austell, Georgia, United States

Site Status

Loyola University Chicago

Chicago, Illinois, United States

Site Status

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, United States

Site Status

University Of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Site Status

University of Louisville Physicians Outpatient Center

Louisville, Kentucky, United States

Site Status

Chest Medicine Associates

South Portland, Maine, United States

Site Status

Mclaren Greater Lansing

Okemos, Michigan, United States

Site Status

Beaumont Hospital Troy

Troy, Michigan, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Albany Medical College

Albany, New York, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Pulmonary Health Physicians, PC

Fayetteville, New York, United States

Site Status

Stony Brook University Medical Center

Islandia, New York, United States

Site Status

Northwell Health- Long Island Jewish Forest Hills

New Hyde Park, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Pinehurst Medical Clinic, INC.

Pinehurst, North Carolina, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

INTEGRIS Nazih Zuhdi Transplant Institution

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Site Status

University of Pittsburgh - Heart and Vascular Medicine Institute

Pittsburgh, Pennsylvania, United States

Site Status

AnMed Health Pulmonary and Sleep Medicine

Anderson, South Carolina, United States

Site Status

Center for Biomedical Research

Knoxville, Tennessee, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Houston Methodist Research Institute

Houston, Texas, United States

Site Status

Renovatio Clinical

The Woodlands, Texas, United States

Site Status

Carilion Clinic

Roanoke, Virginia, United States

Site Status

Heart Care Associates, LLC

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TDE-PH-401

Identifier Type: -

Identifier Source: org_study_id

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