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Inhaled treprostinil became commercially available in the US following its approval for PH-ILD
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This is a multicenter, open-label 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 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Treprostinil | Experimental | Open-label access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Treprostinil | Drug | Inhaled treprostinil up to 15 breaths (90 mcg) four times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline 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 6 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 6MWT within 10 to 60 minutes after the most recent dose of study drug dose. | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline | 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 each visit through Week 124. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT). |
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Inclusion Criteria:
Subject voluntarily gives informed consent to participate in the study.
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.
Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at Baseline) and non-lactating, and will:
Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| IMC-Diagnostic & Medical Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Treprostinil | Open-label access Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily and titrated up to a maximum of 12 breaths four times daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2016 | Jun 1, 2022 |
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| Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) |
| Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline | Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Vital Capacity (FVC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Weeks 12, 48, and 108. | Baseline and Weeks 12, 48, and 108 |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Arizona Pulmonary Specialists, Ltd. | Phoenix | Arizona | 85012 | United States |
| University of Arizona | Tucson | Arizona | 85724 | United States |
| Cedars-Sinai Medical Center | Beverly Hills | California | 90211 | United States |
| University of California, San Francisco-Fresno | Fresno | California | 93701 | United States |
| University of California San Diego | La Jolla | California | 92093 | United States |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Department of Veterans Affairs Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| Pacific Pulmonary Medical Group | Riverside | California | 92505 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente | San Francisco | California | 94115 | United States |
| University of Colorado Hospital - Cardiac and Vascular Center | Aurora | Colorado | 80045 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| MedStar Heart & Vascular Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Lung, Asthma & Sleep Specialists, P.A. | Celebration | Florida | 34747 | United States |
| St. Francis Sleep, Allergy and Lung Institute | Clearwater | Florida | 33765 | United States |
| University of Florida Clinical Research Center | Gainesville | Florida | 32610 | United States |
| University of Florida College of Medicine, Jacksonville | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| St. Vincent's Lung, Sleep, and Critical Care Specialists | Jacksonville | Florida | 33204 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Piedmont - Georgia Lung Associates | Austell | Georgia | 30106 | United States |
| Wellstar Medical Group | Marietta | Georgia | 30060 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago Hospital | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| Community Heart and Vascular Hospital | Indianapolis | Indiana | 46250 | United States |
| St. Vincent Medical Group, Inc. | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Louisville Physicians Outpatient Center | Louisville | Kentucky | 40202 | United States |
| Louisiana State University Health Sciences Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Maine Medical Center | South Portland | Maine | 04106 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Spectrum Health Medical Center | Grand Rapids | Michigan | 49503 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University Hospital | St Louis | Missouri | 63110 | United States |
| The University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Northwell Health | New Hyde Park | New York | 11040 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Pinehurst Medical Clinic, Inc. | Pinehurst | North Carolina | 28374 | United States |
| The Carl and Edyth Lindner Research Center at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati Health | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43221 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| AnMed Health Pulmonary and Sleep Medicine | Anderson | South Carolina | 29621 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Statcare Pulmonary Consultants | Knoxville | Tennessee | 37919 | United States |
| Baylor University Medical Center at Dallas | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Vermont, Vermont Lung Center | Colchester | Vermont | 05446 | United States |
| Inova Fairfax Hospital | Fairfax | Virginia | 22042 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| Pulmonary Associates of Richmond | Richmond | Virginia | 23229 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Alliance Cardio Pulmonary Research Group, Inc. | Guaynabo | 00968 | Puerto Rico |
| Received Inhaled Treprostinil in RIN-PH-202 (Safety Population) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Treprostinil | Open-label access Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily and titrated up to a maximum of 12 breaths four times daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Time Since Diagnosis | Median | Full Range | years |
| |||||||||||||||||
| Current Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||
| 6-Minute Walk Distance (6MWD) | Only 229 subjects had a Baseline 6MWD | Median | Full Range | meters |
| ||||||||||||||||
| N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Only 240 subjects had a Baseline NT-proBNP measurement | Median | Full Range | pg/mL |
| ||||||||||||||||
| Pulmonary Vascular Resistance | Median | Full Range | Wood units |
| |||||||||||||||||
| Mean Pulmonary Artery Pressure | Median | Full Range | mmHg |
| |||||||||||||||||
| Pulmonary Capillary Wedge Pressure | Median | Full Range | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Peak 6-Minute Walk Distance (6MWD) From Baseline | The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline 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 6 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 6MWT within 10 to 60 minutes after the most recent dose of study drug dose. | Values are combined data from the Safety Populations of parent study RIN-PH-201 (n=326; NCT02630316) and this open-label extension study RIN-PH-202 (n=243) as presented in the RIN-PH-202 CSR over the course of 124 weeks (16-week treatment in RIN-PH-201 and up to 108 weeks in RIN-PH-202). The number of subjects analyzed at each week decreased as only those remaining on RIN-PH-202 who had not discontinued early due to the reasons show in the Participant Flow section were evaluated. | Posted | Median | Full Range | meters | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline | 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 each visit through Week 124. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT). | RIN-PH-202 CSR over the course of 124 weeks (16-week treatment in RIN-PH-201 and up to 108 weeks in RIN-PH-202). The number of subjects analyzed at each week decreased as only those remaining on RIN-PH-202 who had not discontinued early due to the reasons show in the Participant Flow section were evaluated. | Posted | Median | Full Range | pg/mL | Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) |
|
| ||||||||||||||||||||||||||||
| Secondary | Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline | Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Vital Capacity (FVC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Weeks 12, 48, and 108. | Subjects from the Placebo Group in parent study RIN-PH-201 | Posted | Median | Full Range | Percent Predicted FVC | Baseline and Weeks 12, 48, and 108 |
|
|
AEs were recorded throughout the course of the study from the time that each subject signed the ICF until all study assessments were completed, through the time that the study was terminated by the Sponsor (following the approval of inhaled treprostinil for use in patients with PH-ILD), up to 108 weeks.
All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 30 days if the AE extended beyond the final study visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Treprostinil | Open-label access Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily and titrated up to a maximum of 12 breaths four times daily | 56 | 242 | 133 | 242 | 229 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cor pulmonale acute | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| haemorrhagic | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Lower gastrointestinal | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| haemorrhage | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra (22.1) | Systematic Assessment |
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| Death | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDra (22.1) | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Coccidioidomycosis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Infective exacerbation of | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| bronchiectasis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Viral upper respiratory tract | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Respiratory syncytial virus | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDra (22.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDra (22.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDra (22.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra (22.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDra (22.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDra (22.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Combined pulmonary fibrosis and emphysema | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Idiopathic interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Lung cyst | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Atrial appendage closure | Surgical and medical procedures | MedDra (22.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDra (22.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra (22.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDra (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDra (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra (22.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra (22.1) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDra (22.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra (22.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra (22.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDra (22.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDra (22.1) | Systematic Assessment |
|
Institution and/or Principal Investigator agree not to publish or publicly present any results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | United Therapeutics Corp. | 919-485-8350 | clinicaltrials@unither.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2019 | Jun 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D017563 | Lung Diseases, Interstitial |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C427248 | treprostinil |
Not provided
Not provided
Not provided
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Occupational lung disease |
|
| Combined pulmonary fibrosis and emphysema |
|
| Connective tissue disease |
|
|
| Week 12 |
|
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| Week 16 |
|
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| Week 20 |
|
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| Week 28 |
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| Week 40 |
|
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| Week 52 |
|
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| Week 64 |
|
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| Week 76 |
|
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| Week 88 |
|
|
| Week 100 |
|
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| Week 112 |
|
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| Week 124 |
|
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|