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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03045029
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

United Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Heart Care Associates, LLC, Milwaukee, Wisconsin

Status

Recruiting

Address

Heart Care Associates, LLC

Milwaukee, Wisconsin, 53215

Site Contact

Kelsey Krueger

kelsey.krueger@aurora.org

414-649-5097

Renovatio Clinical, The Woodlands, Texas

Status

Recruiting

Address

Renovatio Clinical

The Woodlands, Texas, 77380

Irving, Texas

Status

Recruiting

Address

The University of Texas- Health Science Center & Medical School at Houston

Irving, Texas, 75062

Site Contact

Mary Ayad

mary.ayad@uth.tmc.edu

713-500-7484

Houston Methodist Research Institute, Houston, Texas

Status

Recruiting

Address

Houston Methodist Research Institute

Houston, Texas, 77030

Site Contact

Taniqua Warren

tvwarren@houstonmethodist.org

713-363-9280

Baylor University Medical Center, Dallas, Texas

Status

Recruiting

Address

Baylor University Medical Center

Dallas, Texas, 75246

Site Contact

Jessica Propps

jessica.propps@bswhealth.org

(919) 425-5492

Center for Biomedical Research, Knoxville, Tennessee

Status

Recruiting

Address

Center for Biomedical Research

Knoxville, Tennessee, 37919

Site Contact

Krista Tibbs

ktibbs@biomed-research.com

(919) 425-5492

Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

Site Contact

Andrew Sage

sagea@ohsu.edu

503-494-6994

Oklahoma City, Oklahoma

Status

Recruiting

Address

INTEGRIS Nazih Zuhdi Transplant Institution

Oklahoma City, Oklahoma, 73112

Site Contact

Kristen Mund

kristin.mund@integrisOK.com

405-713-4413

The Toledo Hospital- Promedical Health, Toledo, Ohio

Status

Recruiting

Address

The Toledo Hospital- Promedical Health

Toledo, Ohio, 43606

Site Contact

Tiffanie Barnhizer

tiffanie.barnhizer@promedica.org

419-291-7820

Pinehurst Medical Clinic, INC., Pinehurst, North Carolina

Status

Recruiting

Address

Pinehurst Medical Clinic, INC.

Pinehurst, North Carolina, 28374

Site Contact

Rebecca Meyer

rmeyer@pinehurstmedical.com

(919) 425-5492

New Hyde Park, New York

Status

Recruiting

Address

Northwell Health- Long Island Jewish Forest Hills

New Hyde Park, New York, 11040

Site Contact

Sameer Verma

SVerma3@northwell.edu

516-465-5437

Stony Brook University Medical Center, Islandia, New York

Status

Recruiting

Address

Stony Brook University Medical Center

Islandia, New York, 11790

Pulmonary Health Physicians, PC, Fayetteville, New York

Status

Recruiting

Address

Pulmonary Health Physicians, PC

Fayetteville, New York, 13066

Site Contact

Victoria Gabris

Victoria.Gabris@CNYLungs.com

(919) 425-5492

New York Methodist Hospital, Brooklyn, New York

Status

Recruiting

Address

New York Methodist Hospital

Brooklyn, New York, 11215

Site Contact

Puja Chadha

puc9004@nyp.org

718-780-5906

Albany Medical College, Albany, New York

Status

Recruiting

Address

Albany Medical College

Albany, New York, 12208

Site Contact

Sukhu Indrawattie

sukhui1@mail.amc.edu

(919) 425-5492

Barnabas Health Lung Center, Newark, New Jersey

Status

Recruiting

Address

Barnabas Health Lung Center

Newark, New Jersey, 07112

Site Contact

Maya Pandey

mpandey@barnabashealth.org

973-926-8578

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

Ryan Weber

ryan.weber@unmc.edu

(919) 425-5492

Beaumont Hospital Troy, Troy, Michigan

Status

Recruiting

Address

Beaumont Hospital Troy

Troy, Michigan, 48085

Site Contact

Coleen Tessmar

ctessmar@beaumont.edu

248-964-8524

Mclaren Greater Lansing, Okemos, Michigan

Status

Recruiting

Address

Mclaren Greater Lansing

Okemos, Michigan, 48864

Site Contact

Katie Wray Esckilsen

katie.esckilsen@mclaren.org

517-975-9424

Chest Medicine Associates, South Portland, Maine

Status

Recruiting

Address

Chest Medicine Associates

South Portland, Maine, 04106

Site Contact

Kelsey Wollen

kwollen@cmamaine.com

207-828-1122

Louisville, Kentucky

Status

Recruiting

Address

University of Louisville Physicians Outpatient Center

Louisville, Kentucky, 40202

Site Contact

Joan Hamlyn

Joan.hamlyn@louisville.edu

502-852-8739

University Of Iowa Hospital and Clinics, Iowa City, Iowa

Status

Recruiting

Address

University Of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

Site Contact

Cynthia Larew

cynthia-larew@uiowa.edu

319-353-5245

Indianapolis, Indiana

Status

Recruiting

Address

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, 46260

Site Contact

Bonnita Reilly

bonita.reilly@ascension.org

317-338-6161

Comprehensive Cardiovascular Care, LLC, Gurnee, Illinois

Status

Recruiting

Address

Comprehensive Cardiovascular Care, LLC

Gurnee, Illinois, 60031

Site Contact

Samantha Smith

researchcoordinator@C3Gurnee.com

(919) 425-5492

Loyola University Chicago, Chicago, Illinois

Status

Recruiting

Address

Loyola University Chicago

Chicago, Illinois, 60153

Site Contact

Filip Wilk

fwilk@luc.edu

708-216-2028

Cleveland Clinic Florida, Weston, Florida

Status

Recruiting

Address

Cleveland Clinic Florida

Weston, Florida, 33331

Site Contact

Norma Jean Barton

bartonn2@ccf.org

954-659-6213

USF South Florida Heart Health, Tampa, Florida

Status

Recruiting

Address

USF South Florida Heart Health

Tampa, Florida, 33606

Site Contact

Carol Rauen

crauen@tgh.org

813-844-7647

Central Florida Pulmonary Group, P.A., Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group, P.A.

Orlando, Florida, 32803

Site Contact

Sharon Foust

sfoust@cfpulmonary.com

(919) 425-5492

Jacksonville, Florida

Status

Recruiting

Address

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

Jacksonville, Florida, 33204

Site Contact

Iris Orengo, RN

Iris.Orengo@ascension.org

904-354-8200

Gainesville, Florida

Status

Recruiting

Address

University of Florida Clinical Research Center

Gainesville, Florida, 32610

Site Contact

Christina Eagan

eagancm@medicine.ufl.edu

(919) 425-5492

Aurora Denver Cardiology Associates, Aurora, Colorado

Status

Recruiting

Address

Aurora Denver Cardiology Associates

Aurora, Colorado, 80012

Site Contact

Melinda Washam

Melinda.washam@healthonecares.com

303-839-7789

Santa Barbara Pulmonary Associates, Santa Barbara, California

Status

Recruiting

Address

Santa Barbara Pulmonary Associates

Santa Barbara, California, 93105

Site Contact

Vinh Truong

VinhT@sblung.com

805-898-8840 #132

Paloma Medical Group, San Juan Capistrano, California

Status

Recruiting

Address

Paloma Medical Group

San Juan Capistrano, California, 92675

Site Contact

Dina Abdo

dina@palomamedical.com

(919) 425-5492

Los Angeles, California

Status

Recruiting

Address

University of Southern California - Keck Medical Center

Los Angeles, California, 90033

Site Contact

Anton Akulov

anton.akulov@med.usc.edu

323-409-7594

University of California - San Francisco, Fresno, California

Status

Recruiting

Address

University of California - San Francisco

Fresno, California, 94143

Site Contact

Rebekah Garcia

rgarcia@fresno.uscf.edu

559-499-6636

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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