Trial · NCT05649748
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
NCT05649748, Phase 2, Phase 3, Active not recruiting, Insmed Incorporated
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH). Trials, record NCT05649748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05649748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT05649748
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Insmed Incorporated
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Treprostinil Palmitil, Placebo
- First posted
- 2022-12-14
- Last updated
- 2026-10-20
- Other registries' IDs
- eudract:2022-001951-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity | From screening up to last follow up visit (Up to approximately 26 months) | |
| Secondary | Absolute Change From Pre-Open Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD) | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 | |
| Secondary | Relative Change From Pre-OLE Baseline in 6MWD | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 | |
| Secondary | Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 | |
| Secondary | Change From Pre-OLE Baseline in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Score | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 | |
| Secondary | Change From Pre-OLE Baseline in New York Heart Association/ World Health Organization (NYHA/WHO) Functional Capacity Class | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 | |
| Secondary | Annualized Clinical Worsening Event Rate | OLE Baseline (Day 1) up to Month 24 or early discontinuation | Annualized clinical worsening event rate is defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period. Clinical worsening events are one of the following: All-cause death, or onset of TEAE with a fatal outcome occurring ≤ 14 days after study drug discontinuation; Hospitalization for right heart failure (for \> 48 hours), heart-lung or lung transplant, or atrial septostomy; Addition (or increase in dose) of specified PAH-specific medications; Combined occurrence of events including ≥20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure from baseline. |
| Secondary | Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE) | OLE Baseline (Day 1), Months 6, 12, 18, and 24 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05649748
GET https://conductscience.org/api/trials/v1/NCT05649748/registered