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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).
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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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. |
NCT02630316 |
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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. |
Phase 2/Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
United Therapeutics |
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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 |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Puerto Rico, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema |
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.
Status
Recruiting
Address
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
Status
Recruiting
Address
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Status
Recruiting
Address
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
Status
Recruiting
Address
University of Washington Medical Center
Seattle, Washington, 98195
Status
Recruiting
Address
Pulmonary Associates of Richmond
Richmond, Virginia, 23229
Status
Recruiting
Address
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
Status
Recruiting
Address
Inova Fairfax Hospital
Fairfax, Virginia, 22042
Status
Recruiting
Address
University of Vermont, Vermont Lung Center
Colchester, Vermont, 05446
Status
Withdrawn
Address
Scott & White Memorial Hospital
Temple, Texas, 76508
Site Contact
Status
Recruiting
Address
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Status
Recruiting
Address
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Status
Recruiting
Address
Houston Methodist
Houston, Texas, 77030
Status
Recruiting
Address
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Status
Recruiting
Address
UT Southwestern Medical Center
Dallas, Texas, 75390
Status
Recruiting
Address
Baylor University Medical Center at Dallas
Dallas, Texas, 75246
Status
Recruiting
Address
Statcare Pulmonary Consultants
Knoxville, Tennessee, 37919
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Status
Withdrawn
Address
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Site Contact
Status
Recruiting
Address
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Lancaster General Health
Lancaster, Pennsylvania, 17603
Status
Withdrawn
Address
The Oregon Clinic - Pulmonary, Critical Care and Sleep Medicine - West
Portland, Oregon, 97225
Site Contact
Status
Withdrawn
Address
Legacy Research Institute
Portland, Oregon, 97210
Site Contact
Status
Recruiting
Address
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Status
Withdrawn
Address
The University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, 73104
Site Contact
Status
Not yet recruiting
Address
The Ohio State University Medical Center
Columbus, Ohio, 43221
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Completed
Address
University of Cincinnati Health
Cincinnati, Ohio, 45267
Site Contact
Status
Recruiting
Address
The Carl and Edyth Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
Status
Recruiting
Address
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, 28374
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Weill Cornell Medical Center
New York, New York, 10065
Status
Recruiting
Address
The Mount Sinai Hospital
New York, New York, 10029
Status
Recruiting
Address
NYU Langone Medical Center
New York, New York, 10016
Status
Withdrawn
Address
ICAHN School of Medicine - Mount Sinai Beth Israel
New York, New York, 10003
Site Contact
Status
Recruiting
Address
Northwell Health
New Hyde Park, New York, 11040
Status
Withdrawn
Address
Winthrop University Hospital
Mineola, New York, 11501
Site Contact
Status
Recruiting
Address
Pulmonary Health Physicians, PC
Fayetteville, New York, 13066
Status
Recruiting
Address
New York Methodist Hospital
Brooklyn, New York, 11215
Status
Recruiting
Address
Albany Medical College
Albany, New York, 12208
Status
Recruiting
Address
The University of New Mexico
Albuquerque, New Mexico, 87131
Status
Recruiting
Address
Saint Mary's Regional Medical Center
Reno, Nevada, 89503
Status
Withdrawn
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Contact
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Recruiting
Address
University of Minnesota
Minneapolis, Minnesota, 55455
Status
Withdrawn
Address
Mclaren Greater Lansing
Okemos, Michigan, 48864
Site Contact
Status
Recruiting
Address
Spectrum Health Medical Center
Grand Rapids, Michigan, 49503
Status
Withdrawn
Address
Henry Ford Health System
Detroit, Michigan, 48202
Site Contact
Status
Recruiting
Address
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Status
Recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Johns Hopkins University
Baltimore, Maryland, 21205
Status
Recruiting
Address
University of Maryland Medical Center
Baltimore, Maryland, 21201
Status
Recruiting
Address
Maine Medical Center
South Portland, Maine, 04106
Status
Withdrawn
Address
Tulane University
New Orleans, Louisiana, 70112
Site Contact
Status
Recruiting
Address
Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Status
Recruiting
Address
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, 40202
Status
Recruiting
Address
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
Status
Recruiting
Address
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Status
Recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Status
Recruiting
Address
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260
Status
Recruiting
Address
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
Status
Recruiting
Address
Indiana University Hospital
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Lutheran Medical Group
Fort Wayne, Indiana, 46804
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Recruiting
Address
University of Chicago Medical Center
Chicago, Illinois, 60637
Status
Recruiting
Address
University of Illinois at Chicago Hospital
Chicago, Illinois, 60612
Status
Recruiting
Address
Rush University Medical Center
Chicago, Illinois, 60612
Status
Completed
Address
Northwestern University
Chicago, Illinois, 60611
Site Contact
Status
Recruiting
Address
Wellstar Medical Group
Marietta, Georgia, 30060
Status
Recruiting
Address
Hamilton Mill Clinical Research
Dacula, Georgia, 30019
Status
Recruiting
Address
Piedmont - Georgia Lung Associates
Austell, Georgia, 30106
Status
Recruiting
Address
The Emory Clinic
Atlanta, Georgia, 30322
Status
Recruiting
Address
Cleveland Clinic Florida
Weston, Florida, 33331
Status
Recruiting
Address
University of South Florida
Tampa, Florida, 33606
Status
Recruiting
Address
South Miami Heart Specialists
South Miami, Florida, 33143
Status
Recruiting
Address
Florida Hospital
Orlando, Florida, 32804
Status
Recruiting
Address
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803
Status
Recruiting
Address
University of Miami
Miami, Florida, 33136
Status
Recruiting
Address
Miami VA Medical Center
Miami, Florida, 33125
Status
Recruiting
Address
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, 33204
Status
Recruiting
Address
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Status
Recruiting
Address
University of Florida College of Medicine, Jacksonville
Jacksonville, Florida, 32209
Status
Recruiting
Address
University of Florida Clinical Research Center
Gainesville, Florida, 32610
Status
Completed
Address
St. Francis Sleep, Allergy and Lung Institute
Clearwater, Florida, 33765
Site Contact
Status
Recruiting
Address
Florida Lung, Asthma & Sleep Specialists, P.A.
Celebration, Florida, 34747
Status
Recruiting
Address
MedStar Heart & Vascular Institute
Washington, District of Columbia, 20010
Status
Recruiting
Address
Georgetown University Hospital
Washington, District of Columbia, 20007
Status
Completed
Address
Yale New Haven Hospital
New Haven, Connecticut, 06510
Site Contact
Status
Recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Recruiting
Address
University of Colorado Hospital - Cardiac and Vascular Center
Aurora, Colorado, 80045
Status
Withdrawn
Address
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Site Contact
Status
Recruiting
Address
University of California San Francisco
San Francisco, California, 94143
Status
Recruiting
Address
Kaiser Permanente
San Francisco, California, 94115
Status
Completed
Address
University of California Davis Medical Center
Sacramento, California, 95817
Site Contact
Status
Recruiting
Address
Kaiser Permanente - Roseville
Roseville, California, 95825
Status
Recruiting
Address
Pacific Pulmonary Medical Group
Riverside, California, 92505
Status
Recruiting
Address
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Status
Recruiting
Address
University of Southern California
Los Angeles, California, 90033
Status
Recruiting
Address
VA Long Beach Healthcare System
Long Beach, California, 90822
Status
Recruiting
Address
University of California San Diego
La Jolla, California, 92093
Status
Recruiting
Address
University of California San Francisco - Fresno
Fresno, California, 93701
Status
Recruiting
Address
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Status
Recruiting
Address
University of Arizona
Tucson, Arizona, 85724
Status
Completed
Address
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Site Contact
Status
Recruiting
Address
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85012
Status
Withdrawn
Address
University of South Alabama Medical Center
Mobile, Alabama, 36617
Site Contact
Status
Recruiting
Address
IMC-Diagnostic & Medical Clinic
Mobile, Alabama, 36604
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Status
Recruiting
Address
Alliance Cardio Pulmonary Research Group, Inc.
Guaynabo, , 00968
The Pulmonary Fibrosis Foundation rates among top charities in the U.S. The PFF has a three-star rating from Charity Navigator and is a Better Business Bureau accredited charity.
