Trial Outcomes & Findings for A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH) (NCT NCT04791514)
NCT ID: NCT04791514
Last Updated: 2023-09-22
Results Overview
TERMINATED
PHASE2
1 participants
Up to 150 days
2023-09-22
Participant Flow
The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Participant milestones
| Measure |
Treprostinil Palmitil Inhalation Powder (TPIP)
Participant received a single dose of TPIP 112.5 micrograms (μg) via oral inhalation on Day 1. The participant then entered into a 16-week Extended Use Treatment (EUT) Period during which TPIP, administered via oral inhalation, was titrated up to a mean daily dose of 320 μg.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to 150 daysPopulation: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Pre-treatment (Baseline), 8 and 24 hours post-treatmentPopulation: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose up to Day 2Population: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose up to Day 2Population: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose up to Day 2Population: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose up to Day 2Population: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and multiple timepoints post-dose up to Day 2Population: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
Adverse Events
Treprostinil Palmitil Inhalation Powder (TPIP)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60