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Trial record 1 of 1 for:    A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil
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Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

This study is currently recruiting participants.
Verified November 2017 by United Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02630316
First Posted: December 15, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
  Purpose
This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

Condition Intervention Phase
Pulmonary Hypertension Interstitial Lung Disease Combined Pulmonary Fibrosis and Emphysema Drug: Inhaled Treprostinil Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Change in 6-minute Walk Distance (6MWD) Measured at Peak Exposure from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
    The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation. Peak exposure 6MWD will occur by conducting 6-minute walk test (6MWT) within 10 to 60 minutes after the most recent dose of study drug dose.


Secondary Outcome Measures:
  • Change in Peak 6-minute Walk Distance (6MWD) from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
    The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation. Peak exposure 6MWD will occur by conducting 6-minute walk test (6MWT) within 10 to 60 minutes after the most recent dose of study drug dose.

  • Change in Trough 6-minute Walk Distance (6MWD) from Baseline to Week 15 [ Time Frame: Baseline and Week 15 ]
    The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 15, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation. Trough exposure 6MWD will occur by conducting 6-minute walk test (6MWT) at least four hours after the most recent study drug dose.

  • Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16 [ Time Frame: Baseline and Week 16 ]
    The N-terminal pro-BNP (NT-proBNP) serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 16. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT).


Estimated Enrollment: 314
Actual Study Start Date: May 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo inhaled using an ultrasonic nebulizer four times daily
Drug: Placebo
Placebo administered four times daily
Active Comparator: Active Inhaled Treprostinil
Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily
Drug: Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered four times daily
Other Name: Tyvaso

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject voluntarily gives informed consent to participate in the study.
  2. Males and females aged 18 years or older at the time of informed consent.

    a. Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at screening) and non-lactating, and will: i. Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or ii. Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.

    b. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

  3. The subject has a confirmed diagnosis of WHO Group 3 PH based on CT imaging, which demonstrates evidence of diffuse parenchymal lung disease performed within 6 months prior to randomization. Subjects may have any form of ILD or CPFE.
  4. Subjects are required to have a right heart catheterization (RHC) within one year prior to randomization with the following documented parameters:

    1. Pulmonary vascular resistance (PVR) > 3 Wood Units (WU) and
    2. A pulmonary capillary wedge pressure (PCWP) of < 15 mmHg and and
    3. A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg
  5. Baseline 6MWD ≥ 100 meters
  6. Subjects on a chronic medication for underlying lung disease (ie, pirfenidone, nintedanib, etc) must be on a stable and optimized dose for ≥ 30 days prior to randomization. Subjects receiving pirfenidone or nintedanib must have been receiving treatment for at least 90 days and on a stable dose for at least 30 days prior to randomization.
  7. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits.
  8. Subjects with connective tissue disease (CTD) must have a Baseline FVC of < 70%.

Exclusion criteria:

  1. The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3.
  2. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
  3. The subject has received any PAH approved therapy including: prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonist (selexipag), endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor (PDE-5I), or soluble guanylate cyclase (sGC) within 60 days of randomization.
  4. The subject has evidence of clinically significant left-sided heart disease as defined by:

    1. PCWP > 15 mmHg
    2. Left ventricular ejection fraction < 40%.

    Note: Subjects with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload (i.e., right ventricular hypertrophy and/or dilatation) will not be excluded.

  5. The subject is receiving > 10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
  6. Current use of any inhaled tobacco/marijuana products or significant history of drug abuse at the time of informed consent.
  7. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of randomization.
  8. Initiation of pulmonary rehabilitation within 12 weeks prior to the randomization.
  9. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or has any disease or condition (ie, peripheral vascular disease, musculoskeletal disorder, morbid obesity) that would likely be the primary limit to ambulation (as opposed to PH).
  10. Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.
  11. Severe concomitant illness limiting life expectancy (< 6 months).
  12. Acute pulmonary embolism within 90 days of randomization.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630316


Contacts
Contact: Kristan Rollins krollins@unither.com
Contact: Millicent Clark mclark@unither.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Dorothy Nieters    205-975-4387    dnieters@uabmc.edu   
Principal Investigator: Robert Bourge, MD         
IMC-Diagnostic & Medical Clinic Recruiting
Mobile, Alabama, United States, 36604
Contact: Deborah Barnett    251-435-1651    deborah.barnett@infirmaryhealth.org   
Principal Investigator: Adrian DiVittorio, MD         
United States, Arizona
Arizona Pulmonary Specialists, Ltd. Recruiting
Phoenix, Arizona, United States, 85012
Contact: Nidhi Samaraweera    602-271-0832    nidhi-research@hotmail.com   
Principal Investigator: Jeremy Feldman, MD         
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Georgann VanderJagt, RN    602-406-3825    georgann.vanderjagt@dignityhealth.org   
Principal Investigator: Rajat Walia, MD         
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Valerie Bloss    520-626-8305    vbloss@email.arizona.edu   
Principal Investigator: Franz Rischard, DO         
United States, California
University of California San Francisco - Fresno Recruiting
Fresno, California, United States, 93701
Contact: Sonia Garcia    559-499-6637    sgarcia@fresno.ucsf.edu   
Principal Investigator: Vijay Balasubramanian         
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Diane Vang    858-657-7122    djvang@ucsd.edu   
Principal Investigator: Poch David, MD         
Department of Veterans Affairs Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Harold Te    310-268-4314    harold.te@va.gov   
Principal Investigator: Shapiro Shelley, MD         
Pacific Pulmonary Medical Group Recruiting
Riverside, California, United States, 92505
Contact: Mostafa Elsiah    951-373-5827    mostafa.ppmg@gmail.com   
Principal Investigator: Heba Ismail, MD         
Kaiser Permanente - Roseville Recruiting
Roseville, California, United States, 95825
Contact: Tashia Orr    916-973-4885    Tashia.Orr@kp.org   
Principal Investigator: Sachin Gupta, MD         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Macey Sockolov    916-734-1554    mlsockolov@ucdavis.edu   
Principal Investigator: Roblee Allen         
Kaiser Permanente Recruiting
San Francisco, California, United States, 94115
Contact: Quyen Chau       quyen.x.chau@kp.org   
Principal Investigator: Sachin Gupta, MD         
United States, Colorado
University of Colorado Hospital - Cardiac and Vascular Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Cheryl Abbott, RN, CCRP    303-724-7466    cheryl.abbott@ucdenver.edu   
Principal Investigator: Todd Bull, MD         
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Kris Eliopoulos    303-270-2622    eliopoulosk@njhealth.org   
Principal Investigator: Amy Olson, MD         
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Michele Cooney    202-444-0895    Cooneym@gunet.georgetown.edu   
Principal Investigator: Tunay Kuru, MD         
MedStar Heart & Vascular Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Sara Ahmed       sara.ahmed@medstar.net   
Principal Investigator: Christopher Barnett, MD         
United States, Florida
Florida Lung, Asthma & Sleep Specialists, P.A. Recruiting
Celebration, Florida, United States, 34747
Contact: Donna Krause    407-507-2615 ext 109    dkrause@floridalungdoctors.com   
Principal Investigator: Fred Umeh, MD         
St. Francis Sleep, Allergy and Lung Institute Recruiting
Clearwater, Florida, United States, 33765
Contact: Sarah Hollingshead    727-210-4606    SHollingshead@stfrancismed.com   
Principal Investigator: Francis Averill, MD         
University of Florida College of Medicine, Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Minal Patel    904-244-1106    Minal.patel@jax.ufl.edu   
Principal Investigator: Vandana Seeram, MD         
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Melissa Stratoberdha       Stratoberdha.Melissa@mayo.edu   
Principal Investigator: Charles Burger, MD         
Miami VA Medical Center Recruiting
Miami, Florida, United States, 33125
Contact: Silvana Cobian    305-575-7000 ext 4618    Silvana.Cobian@va.gov   
Principal Investigator: Michael Campos, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Eliana Mendes, MD         
Contact    305-243-2568    emendes@med.miami.edu   
Principal Investigator: David De La Zerda, MD         
Central Florida Pulmonary Group, P.A. Recruiting
Orlando, Florida, United States, 32803
Contact: Sharon Foust       sfoust@cfpulmonary.com   
Principal Investigator: Syed Mobin, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Kimberly Cawthon    407-303-7556    kimberly.cawthon@flhosp.org   
Principal Investigator: James Tarver III, MD         
South Miami Heart Specialists Recruiting
South Miami, Florida, United States, 33143
Contact: Jojie Calderin    305-999-3301    gcalderin@ampmrc.com   
Principal Investigator: Javier Jimenez, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Norma Jean Barton    954-659-6213    bartonn2@ccf.org   
Principal Investigator: Jinesh Mehta, MD         
United States, Georgia
The Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jane Gillespie, RN         
Contact    404-712-8204    jane.gillespie@emory.edu   
Principal Investigator: Micah Fisher, MD         
Piedmont - Georgia Lung Associates Recruiting
Austell, Georgia, United States, 30106
Contact: Elizabeth Wilkins       elizabeth.wilkins@piedmont.org   
Principal Investigator: Amy Case, MD         
Hamilton Mill Clinical Research Recruiting
Dacula, Georgia, United States, 30019
Contact: Terrence Little    470-297-6789    tlittle@vitalinkresearch.com   
Principal Investigator: Rachel Nisbet, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jordyn Durkin    312-695-6292    jdurkin@northwestern.edu   
Principal Investigator: Hector Cajigas, MD         
University of Illinois at Chicago Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Adam Ostrower    312-355-5934    ostrower@uic.edu   
Principal Investigator: Dustin Fraidenburg, MD         
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Sandy Coslet         
Contact    773-864-5768    scoslet@medicine.bsd.uchicago.edu   
Principal Investigator: Remzi Bag, MD         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Jessica Shore    708-216-2027    jshore@luc.edu   
Principal Investigator: James Gagermeier, MD         
United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Erin Turk    317-962-3183    eturk@iuhealth.org   
Principal Investigator: William Harvey, MD         
Community Heart and Vascular Hospital Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Joanna Greene-Nashold, RN    317-621-8629    jgnashold@ecommunity.com   
Principal Investigator: Navneet Lather, MD         
St. Vincent Medical Group, Inc. Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Shawna Dodd, RN    317-338-6252    Shawna.Dodd@ascension.org   
Principal Investigator: Ashwin Ravichandran, MD         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Cynthia Larew    319-353-7953    cynthia-larew@uiowa.edu   
Principal Investigator: Alicia Gerke, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kimberly Lovell    913-588-6067    klovell@kumc.edu   
Principal Investigator: Lewis Satterwhite, MD         
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Christian Soares    859-218-6740    cso232@uky.edu   
Principal Investigator: Ketan Buch, MD         
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Martha Royse, APRN    502-587-8000    roysenp@gmail.com   
Principal Investigator: John McConnell, MD         
University of Louisville Physicians Outpatient Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Joan Hamlyn    502-852-8739    Joan.hamlyn@louisville.edu   
Principal Investigator: Karim El-Kersh, MD         
United States, Louisiana
Louisiana State University Health Sciences Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Paula Lauto, RN    504-568-3451    plauto@lsuhsc.edu   
Principal Investigator: Matthew Lammi, MD         
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sandy Ditta    504-988-4040    sditta@tulane.edu   
Principal Investigator: Shigeki Saito, MD         
United States, Maine
Maine Medical Center Recruiting
South Portland, Maine, United States, 04106
Contact: Christina Manley    207-828-1122    Tmanley@cmamaine.com   
Principal Investigator: Joel Wirth, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Lioubov Poliakova    410-328-6885    lpoliako@medicine.umaryland.edu   
Principal Investigator: Gautam V. Ramani, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Karen Visnaw, RN    617-636-1334    Kvisnaw@tuftsmedicalcenter.org   
Principal Investigator: Nicholas Hill, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lloyd Liang       LLLIANG@mgh.harvard.edu   
Principal Investigator: Sydney Montesi, MD         
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Laurie Lawler, RN    617-525-9731    llawler@partners.org   
Principal Investigator: Aaron B. Waxman, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Jackie Day    313-916-1254    jday5@hfhs.org   
Principal Investigator: Rana Awdish, MD         
Spectrum Health Medical Center Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Molly Cope, RN    616-391-3869    molly.cope@spectrumhealth.org   
Contact: Mya Franzo       mya.franzo@spectrumhealth.org   
Principal Investigator: Reda Girgis, MD         
Mclaren Greater Lansing Recruiting
Okemos, Michigan, United States, 48864
Contact: Katie Wray Esckilsen    517-975-9424    katie.esckilsen@mclaren.org   
Principal Investigator: Majid Mughal         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Gretchen Peichel    612-626-6237    gpeichel@umn.edu   
Principal Investigator: Thenappan Thenappan, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sue Donlinger       Donlinger.sueann@mayo.edu   
Principal Investigator: Hilary DuBrock, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Alycia Harris    601-815-3070    aharris3@umc.edu   
Principal Investigator: John Spurzem, MD         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Patricia Wyman    816-932-5987    pwyman@saint-lukes.org   
Principal Investigator: Mark Yagan, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Traci Nelson    402-559-7585    trnelson@unmc.edu   
Principal Investigator: Austin Thompson, MD         
United States, Nevada
Saint Mary's Regional Medical Center Recruiting
Reno, Nevada, United States, 89503
Contact: Jami-Sue Coleman, PhD       jcoleman@primehealthcare.com   
Contact    775-770-3734      
Principal Investigator: Joseph Stevenson, DO         
United States, New Mexico
The University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Adriana Villalobos    505-925-1160    advillalobos@salud.unm.edu   
Principal Investigator: Lana Melendres-Groves, MD         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Furqan Ilyas    518-262-1542    ilyasf@mail.amc.edu   
Principal Investigator: Boris Medarov, MD         
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Puja Chadha    718-780-5614    puc9004@nyp.org   
Principal Investigator: Ruth Minkin, MD         
Pulmonary Health Physicians, PC Recruiting
Fayetteville, New York, United States, 13066
Contact: Zoe Gonza, RN         
Contact    315-234-0816    Zoe.Gonza@CNYLungs.com   
Principal Investigator: Sherif El Bayadi, MD         
Winthrop University Hospital Withdrawn
Mineola, New York, United States, 11501
Northwell Health Recruiting
New Hyde Park, New York, United States, 11040
Contact: Sameer Verma, MD    516-465-5437    SVerma3@northwell.edu   
Principal Investigator: Arunabh Talwar, MD         
ICAHN School of Medicine - Mount Sinai Beth Israel Withdrawn
New York, New York, United States, 10003
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Ewelina Wojtaszek         
Contact    917-501-5255    ewelina.wojtaszek@mountsinai.org   
Principal Investigator: Maria Trivieri, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dakota Buhrman    919-445-0353    dakota_buhrman@med.unc.edu   
Principal Investigator: Hubert James (Jimmy) Ford III, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susana Almeida-Peters, BN,RN    919-668-2642    susana.almeida-peters@duke.edu   
Principal Investigator: Sudarshan Rajagopal, MD         
Pinehurst Medical Clinic, Inc. Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Rebecca Meyer    910-235-3144    Rmeyer@pinehurstmedical.com   
Principal Investigator: Michael Pritchett, DO         
United States, Ohio
The Carl and Edyth Lindner Research Center at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Christine Lawrence    513-585-1777    christine.lawrence@thechristhospital.com   
Principal Investigator: Peter Engel, MD         
University of Cincinnati Health Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Emilee Orr    513-558-3077    ORREY@ucmail.uc.edu   
Principal Investigator: Jean Elwing, MD         
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mary Andrews       mary.andrews@uhhospitals.org   
Contact    216-844-2386      
Principal Investigator: Robert Schilz, DO         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Mary Beukemann    216-444-2140    beukemm@ccf.org   
Principal Investigator: Joseph Parambil, MD         
The Ohio State University Medical Center Not yet recruiting
Columbus, Ohio, United States, 43221
Contact: Joseph Santiago, RRT, RPFT       joseph.santiago@osumc.edu   
Contact    614-366-4593      
Principal Investigator: Nitin Bhatt, MD         
United States, Oklahoma
The University of Oklahoma Health Sciences Center (OUHSC) Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Lauren Sinko    405-413-7548    laurel-howard@ouhsc.edu   
Principal Investigator: Himanshu Bhardwaj, MD         
United States, Oregon
Legacy Research Institute Recruiting
Portland, Oregon, United States, 97210
Contact: Tamara Mayfield    503-413-7945    tmayfiel@lhs.org   
Principal Investigator: Catherine Markin, MD         
The Oregon Clinic - Pulmonary, Critical Care and Sleep Medicine - West Recruiting
Portland, Oregon, United States, 97225
Contact: Stephanie Caron       scaron@orclinic.com   
Principal Investigator: Jeffrey Robinson, MD         
United States, Pennsylvania
Lancaster General Health Recruiting
Lancaster, Pennsylvania, United States, 17603
Contact: Lou Anne Kruse, RN, BSN    717-544-1777    lakruse@LGHealth.org   
Principal Investigator: Justin Roberts, DO         
Hospital of University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vanamala Narasimhan    215-294-9756    Vanamala.Narasimhan@uphs.upenn.edu   
Principal Investigator: Kerri Akaya Smith, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gayle Jones, RN    215-707-1041    Gayle.Jones@tuhs.temple.edu   
Principal Investigator: Sheila Weaver, DO         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Joan Rossi, RN    412-359-3293    joan.rossi@ahn.org   
Principal Investigator: Amresh Raina, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jessica Stanard    412-683-7112    mcdadejl@upmc.edu   
Principal Investigator: Michael Risbano         
United States, South Carolina
AnMed Health Pulmonary and Sleep Medicine Recruiting
Anderson, South Carolina, United States, 29621
Contact: Charlesa Davis    864-512-1291    charlesa.davis2@anmedhealth.org   
Principal Investigator: Abhijit Raval, MD         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Robyn Do    843-792-1221    dorobyn@musc.edu   
Principal Investigator: Rahul Argula, MD         
United States, Tennessee
Statcare Pulmonary Consultants Recruiting
Knoxville, Tennessee, United States, 37919
Contact: Krista Tibbs    865-934-2676    ktibbs@biomed-research.com   
Principal Investigator: John Swisher, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Oluwatosin Igenoza    214-645-9730    Oluwatosin.Igenoza@UTSouthwestern.edu   
Principal Investigator: Sonja Bartolome, MD         
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Ann Saulino, RN    713-441-7182    asaulino@houstonmethodist.org   
Principal Investigator: Sandeep Sahay, MD         
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarah Perusich    713-794-7294    Sarah.Perusich@va.gov   
Principal Investigator: Lavannya Pandit, MD         
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Tiffany Ostovar-Kermani    713-500-6851    Tiffany.G.OstovarKermani@uth.tmc.edu   
Principal Investigator: Bela Patel, MD         
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Olga Dib    210-415-1180    Dibo@uthscsa.edu   
Principal Investigator: Deborah Levine, MD         
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Lori Murdoch    254-724-7168    Lori.Murdoch@BSWHealth.org   
Principal Investigator: Peter Yau, MD         
United States, Vermont
University of Vermont, Vermont Lung Center Recruiting
Colchester, Vermont, United States, 05446
Contact: Kathy Meehan    802-847-3627    Kathy.Meehan@uvmhealth.org   
Principal Investigator: Maryellen Antkowiak, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Fairfax, Virginia, United States, 22042
Contact: Priscila Dauphin, MD    703-776-7128    priscila.dauphin@inova.org   
Principal Investigator: Christopher King, MD         
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant    757-388-4024    MMBULLIV@sentara.com   
Principal Investigator: Michael Eggert         
Pulmonary Associates of Richmond Recruiting
Richmond, Virginia, United States, 23229
Contact: Betsy Daniel       bdaniel@paraccess.com   
Principal Investigator: Shilpa Johri, MD         
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53792
Contact: Lori Wollet    608-263-0524    ljwollet@medicine.wisc.edu   
Principal Investigator: James Runo, MD         
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Linda Boehm, RN    414-649-5664    linda.boehm@aurora.org   
Principal Investigator: Dianne Zwicke, MD         
Sponsors and Collaborators
United Therapeutics
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT02630316     History of Changes
Other Study ID Numbers: RIN-PH-201
First Submitted: December 11, 2015
First Posted: December 15, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by United Therapeutics:
Treprostinil
PH
ILD
CPFE
6 Minute Walk Test

Additional relevant MeSH terms:
Treprostinil
Hypertension
Lung Diseases
Hypertension, Pulmonary
Pulmonary Fibrosis
Emphysema
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Pathologic Processes
Antihypertensive Agents