An observational study in Pulmonary Arterial Hypertension, sponsored by United Therapeutics. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by United Therapeutics · Observational
This is an observational, multicenter, single-day, Phase 2 study. This study will include a 14-day Screening Period and Study Day 1 clinic visit. Participants will be required to perform an activity to induce symptoms of PAH, and participants' severity of self-reported symptoms of PAH will be measured from pre-activity, immediately after the activity, and through the 30-minute recovery. Participants will be asked about their PAH symptoms using 3 PGI-S questions that address their overall PAH symptoms, shortness of breath, and physical fatigue.
This is an observational, multicenter, single-day, Phase 2 study. This study will include a 14-day Screening Period and Study Day 1 clinic visit. Participants will be required to perform an activity to induce symptoms of PAH, and participants' severity of self-reported symptoms of PAH will be measured from pre-activity, immediately after the activity, and through the 30-minute recovery. Participants will be asked about their PAH symptoms using 3 Patient Global Impression of Severity (PGI-S) questions that address their overall PAH symptoms, shortness of breath, and physical fatigue.
PAH symptoms will be induced via the Incremental Shuttle Walk Test (ISWT). The ISWT used in this study required the participant to walk back and forth on a 10-meter course. The total number of shuttles completed by a participant during the Screening ISWT will be the maximum targeted for that participant during the remaining ISWTs in the study.
After Screening, participants will be assigned to 1 of 2 cohorts based on PAH medications as prescribed by their physician: Cohort A will include participants who are currently prescribed and using inhaled treprostinil for the treatment of PAH and Cohort B will include participants who are taking other PAH medications (instead of inhaled treprostinil).
The study also includes 2 periods. One period for participants in Cohort A (Treprostinil Users), included an ISWT initiated within 30 minutes of the previous dose (expected peak level) and the other period included an ISWT within 3 to 4 hours of the previous dose of inhaled treprostinil (expected trough level). Participants in Cohort B (Non-Treprostinil Users), an ISWT will be initiated approximately 4 hours after the morning dose of PAH medication (Period 1) and an ISWT initiated at least 1 hour following completion of the previous ISWT (Period 2). Participants will be provided at least a 1-hour period for rest between ISWTs (until participant feels they are rested enough to perform again at their baseline level) prior to Period 2 assessments.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 43 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →United Therapeutics is the lead sponsor of 81 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.
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Males and females aged 18 years and above with a diagnosis of PAH that is either idiopathic or familial PAH (World Health Organization [WHO] Group 1), collagen vascular disease associated PAH, PAH associated with human immunodeficiency virus (HIV) infection, PAH induced by anorexigens/toxins, or PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥1 years).
Exclusion Criteria:
Participants who are currently prescribed and using inhaled treprostinil for the treatment of PAH.
Drug: Treprostinil
Participants who are taking other PAH medications (instead of inhaled treprostinil).
Drug: Non-Treprostinil PAH Medications
Treprostinil treatment will be at the discretion of the participant's physician, and determined on an individual basis.
Non-treprostinil treatment will be at the discretion of the participant's physician, and determined on an individual basis.
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. Peak levels are the highest concentrations of a drug in plasma.
Time frame: Baseline, Approximately 30 m of previous dose of inhaled treprostinil (the expected peak level) on Day 1
Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. Trough levels are the lowest concentrations of a drug in plasma.
Time frame: Baseline, Approximately 3-4 h of previous dose of inhaled treprostinil (the expected trough level) on Day 1
Change From Baseline in PGI-S Score in Cohort B Participants at Approximately 4 Hours After Morning Dose of Non-Treprostinil PAH Medication (Period 1) on Day 1
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value.
Time frame: Baseline, Approximately 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1
Change From Baseline in PGI-S Scores in Cohort B Participants With an ISWT at Least 1 h Following Completion of Previous ISWT (Period 2) on Day 1
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value.
Time frame: Baseline, At least 1 h following completion of previous ISWT (Period 2) on Day 1
Change From Baseline in Modified Borg Dyspnea Scores at Day 1
The modified Borg scale allows participants to rate maximum level of dyspnea experienced during 6-Minute Walk Test (6MWT). Scores ranged from 0 (best condition) to 10 (worst condition). Baseline defined as average from Borg Dyspnea Scores measured at 15 and 0 m prior to ISWT. If a single pre-ISWT Borg Dyspnea Score was missing, the other nonmissing single score was used as baseline value. Change from Baseline=Post-Baseline value - Baseline value. Data for participants in Cohort A with an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Data for participants in Cohort B with an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are highest and lowest concentrations of a drug in plasma.
Time frame: Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1
Change From Baseline in Pulse Oximetry at Day 1
Pulse Oximetry includes the collection of saturation peripheral capillary oxygenation (SpO_2). Baseline was defined as the average from pulse oximetry measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing pre-ISWT pulse oximetry, the other non-missing single measurement would be used as baseline value. Change from Baseline = Post-Baseline value - Baseline value. Data for participants in Cohort A who had an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Additionally, data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are the highest and lowest concentrations of a drug in plasma.
Time frame: Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1
Change From Baseline in Heart Rate at Day 1
Heart rate was captured as beats per minute (bpm). Baseline was defined as the average from pulse oximetry measured at 15 minutes and 0 minute prior to the Incremental Shuttle Walk Test (ISWT). In the case of a single, missing pre-ISWT pulse oximetry, the other non-missing single measurement would be used as baseline value. Change from Baseline = Post-Baseline value - Baseline value. Data for participants in Cohort A who had an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Additionally, data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are the highest and lowest concentrations of a drug in plasma.
Time frame: Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1
The study included a 14-day Screening Period and Day 1 clinic visit. Participants performed a Incremental Shuttle Walk Test (ISWT) to induce symptoms of Pulmonary Arterial Hypertension (PAH). The ISWT required participants to walk back and forth on a 10-meter course. Total number of shuttles completed by a participant during the Screening ISWT was the maximum targeted for the participant for remaining study ISWTs. Study also included 2 periods/cohort. There was ≥1-h rest period between ISWTs.
| Milestone | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Started | 20 | 23 |
| Safety population | 20 | 23 |
| Completed | 20 | 23 |
| Not completed | 0 | 0 |
| Milestone | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Started | 20 | 23 |
| Completed | 20 | 23 |
| Not completed | 0 | 0 |
| Milestone | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Started | 20 | 23 |
| Completed | 20 | 23 |
| Not completed | 0 | 0 |
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. Peak levels are the highest concentrations of a drug in plasma.
| scores on a scale | Cohort A: Treprostinil |
|---|---|
| PAH, Baseline | 1.25 ± 0.47 |
| PAH, Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 1.65 ± 0.80 |
| SOB, Baseline | 1.15 ± 0.33 |
| SOB, Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 1.90 ± 0.80 |
| Fatigue, Baseline | 1.30 ± 0.55 |
| Fatigue, Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 1.40 ± 0.95 |
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. Trough levels are the lowest concentrations of a drug in plasma.
| scores on a scale | Cohort A: Treprostinil |
|---|---|
| PAH, Baseline | 1.10 ± 0.31 |
| PAH, Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 1.75 ± 0.79 |
| SOB, Baseline | 1.10 ± 0.31 |
| SOB, Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 1.85 ± 0.93 |
| Fatigue, Baseline | 1.25 ± 0.44 |
| Fatigue, Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 1.50 ± 1.15 |
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value.
| scores on a scale | Cohort B: Non-Treprostinil PAH Medications |
|---|---|
| PAH, Baseline | 1.22 ± 0.39 |
| PAH, Change at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | 1.74 ± 0.90 |
| SOB, Baseline | 1.17 ± 0.36 |
| SOB, Change at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | 1.78 ± 0.78 |
| Fatigue, Baseline | 1.17 ± 0.36 |
| Fatigue, Change at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | 1.61 ± 1.07 |
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value.
| scores on a scale | Cohort B: Non-Treprostinil PAH Medications |
|---|---|
| PAH, Baseline | 1.13 ± 0.34 |
| PAH, Change at least 1 h following completion of previous ISWT (Period 2) on Day 1 | 1.87 ± 0.97 |
| SOB, Baseline | 1.04 ± 0.21 |
| SOB, Change at least 1 h following completion of previous ISWT (Period 2) on Day 1 | 2.13 ± 0.92 |
| Fatigue, Baseline | 1.13 ± 0.34 |
| Fatigue, Change at least 1 h following completion of previous ISWT (Period 2) on Day 1 | 1.91 ± 1.04 |
The modified Borg scale allows participants to rate maximum level of dyspnea experienced during 6-Minute Walk Test (6MWT). Scores ranged from 0 (best condition) to 10 (worst condition). Baseline defined as average from Borg Dyspnea Scores measured at 15 and 0 m prior to ISWT. If a single pre-ISWT Borg Dyspnea Score was missing, the other nonmissing single score was used as baseline value. Change from Baseline=Post-Baseline value - Baseline value. Data for participants in Cohort A with an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Data for participants in Cohort B with an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are highest and lowest concentrations of a drug in plasma.
| scores on a scale | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Expected peak level, Baseline | 0.28 ± 0.54 | — |
| Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 3.00 ± 1.78 | — |
| Expected trough level, Baseline | 0.23 ± 0.62 | — |
| Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 3.13 ± 2.16 | — |
| Period 1, Baseline | — | 0.24 ± 0.50 |
| Change at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | — | 2.85 ± 1.81 |
| Period 2, Baseline | — | 0.23 ± 0.64 |
| Change at least 1 h following completion of previous ISWT (Period 2) on Day 1 | — | 3.03 ± 1.90 |
Pulse Oximetry includes the collection of saturation peripheral capillary oxygenation (SpO_2). Baseline was defined as the average from pulse oximetry measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing pre-ISWT pulse oximetry, the other non-missing single measurement would be used as baseline value. Change from Baseline = Post-Baseline value - Baseline value. Data for participants in Cohort A who had an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Additionally, data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are the highest and lowest concentrations of a drug in plasma.
| percent saturation (SpO_2) | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Expected peak level, Baseline | 93.73 ± 2.94 | — |
| Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | -8.13 ± 6.68 | — |
| Expected trough level, Baseline | 95.15 ± 3.12 | — |
| Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | -10.35 ± 9.35 | — |
| Period 1, Baseline | — | 94.98 ± 3.24 |
| Change at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | — | -4.85 ± 5.13 |
| Period 2, Baseline | — | 94.04 ± 3.14 |
| Change at least 1 h following completion of previous ISWT (Period 2) on Day 1 | — | -2.91 ± 3.79 |
Heart rate was captured as beats per minute (bpm). Baseline was defined as the average from pulse oximetry measured at 15 minutes and 0 minute prior to the Incremental Shuttle Walk Test (ISWT). In the case of a single, missing pre-ISWT pulse oximetry, the other non-missing single measurement would be used as baseline value. Change from Baseline = Post-Baseline value - Baseline value. Data for participants in Cohort A who had an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Additionally, data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are the highest and lowest concentrations of a drug in plasma.
| bpm | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Expected peak level, Baseline | 80.08 ± 11.93 | — |
| Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 24.48 ± 18.10 | — |
| Expected trough level, Baseline | 75.58 ± 10.78 | — |
| Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 23.08 ± 19.10 | — |
| Period 1, Baseline | — | 74.59 ± 11.67 |
| Change at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | — | 31.28 ± 13.67 |
| Period 2, Baseline | — | 75.26 ± 12.04 |
| Change at least 1 h following completion of previous ISWT (Period 2) on Day 1 | — | 33.39 ± 18.08 |
Collected over Baseline through Day 1 (up to at least 5 hours or at the Investigator's discretion). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: Treprostinil | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Cohort B: Non-Treprostinil PAH Medications | 0/23 (0%) | 0/23 (0%) | 9/23 (39.1%) |
| Event | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications |
|---|---|---|
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/20 | 2/23 |
| DiarrhoeaGastrointestinal disorders | 0/20 | 1/23 |
| VomitingGastrointestinal disorders | 0/20 | 1/23 |
| ChillsGeneral disorders | 0/20 | 1/23 |
| FatigueGeneral disorders | 0/20 | 1/23 |
| Non-cardiac chest painGeneral disorders | 0/20 | 1/23 |
| BronchitisInfections and infestations | 0/20 | 1/23 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/20 | 1/23 |
All Participants: Participants who consented to the study protocol.
| Age, Continuous(years) | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications | Total |
|---|---|---|---|
| Mean | 61.2 ± 8.69 | 55.9 ± 13.14 | 58.3 ± 11.48 |
| Sex: Female, Male(Participants) | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications | Total |
|---|---|---|---|
| Female | 16 | 17 | 33 |
| Male | 4 | 6 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 19 | 21 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort A: Treprostinil | Cohort B: Non-Treprostinil PAH Medications | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 14 | 18 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
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