Pulmonary Arterial Hypertension
Conditions
Keywords
Remodulin, 6-Minute Walk Test
Brief summary
This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.
Interventions
DRUGIntravenous Treprostinil
Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Sponsors
United Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)
Exclusion criteria
* Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) | The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit | The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living. |
| Effect of Long-term Remodulin Therapy on the NYHA Functional Classification | The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit | The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment). |
| Effect of Long-term Remodulin Therapy on Subject Safety | Baseline to Week 12 | Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Treprostinil Intravenous treprostinil was supplied as 1 mg/mL.
Remodulin (Intravenous Treprostinil): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 6 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Study terminated by Sponsor | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Intravenous Treprostinil |
|---|---|
| Age, Continuous | 30.1 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment India | 16 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 16 |
| other Total, other adverse events | 14 / 16 |
| serious Total, serious adverse events | 14 / 16 |
Outcome results
Primary
Effect of Long-term Remodulin Therapy on Subject Safety
Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).
Time frame: Baseline to Week 12
Population: Intent-to-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Treprostinil | Effect of Long-term Remodulin Therapy on Subject Safety | 14 Participants |
Primary
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Time frame: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Population: Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Treprostinil | Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) | 440.8 Meters | Standard Deviation 108.6 |
Primary
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
Time frame: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
Population: Data presented include all subjects who underwent an NYHA functional classification assessment at their final visit. Not all subjects underwent an NYHA assessement at their final visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravenous Treprostinil | Effect of Long-term Remodulin Therapy on the NYHA Functional Classification | 2.1 Functional Class | Standard Deviation 0.6 |