An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
NCT ID: NCT02633293
Last Updated: 2022-12-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
243 participants
INTERVENTIONAL
2016-09-15
2021-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inhaled Treprostinil
Open-label access
Inhaled Treprostinil
Inhaled treprostinil up to 15 breaths (90 mcg) four times daily
Interventions
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Inhaled Treprostinil
Inhaled treprostinil up to 15 breaths (90 mcg) four times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject participated in study RIN-PH-201, remained on study drug, was compliant with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that the study was discontinued by the sponsor.
3. Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at Baseline) and non-lactating, and will:
* Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
* Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.
4. Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
Exclusion Criteria
2. The subject was prematurely discontinued from study RIN-PH-201.
3. The subject developed a concurrent illness or condition during the conduct of RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
IMC-Diagnostic & Medical Clinic
Mobile, Alabama, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
University of California, San Francisco-Fresno
Fresno, California, United States
University of California San Diego
La Jolla, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States
Pacific Pulmonary Medical Group
Riverside, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Kaiser Permanente
San Francisco, California, United States
University of Colorado Hospital - Cardiac and Vascular Center
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Heart & Vascular Institute
Washington D.C., District of Columbia, United States
Florida Lung, Asthma & Sleep Specialists, P.A.
Celebration, Florida, United States
St. Francis Sleep, Allergy and Lung Institute
Clearwater, Florida, United States
University of Florida Clinical Research Center
Gainesville, Florida, United States
University of Florida College of Medicine, Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
Piedmont - Georgia Lung Associates
Austell, Georgia, United States
Wellstar Medical Group
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, United States
Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana, United States
Maine Medical Center
South Portland, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Spectrum Health Medical Center
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University Hospital
St Louis, Missouri, United States
The University of New Mexico
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Northwell Health
New Hyde Park, New York, United States
NYU Langone Medical Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, United States
The Carl and Edyth Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati Health
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Statcare Pulmonary Consultants
Knoxville, Tennessee, United States
Baylor University Medical Center at Dallas
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Houston Methodist
Houston, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Vermont, Vermont Lung Center
Colchester, Vermont, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Pulmonary Associates of Richmond
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Alliance Cardio Pulmonary Research Group, Inc.
Guaynabo, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RIN-PH-202
Identifier Type: -
Identifier Source: org_study_id
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