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An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
NCT05649748 · View on ClinicalTrials.gov ↗
Study Summary
The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Treprostinil Palmitil
Study Locations (20)
Other
- ARG004 — Córdoba
- ARG001 — Córdoba
- AUT001 — Vienna
- BEL003 — Brussels
Florida
- USA005 — Jacksonville
- USA011 — Tampa
Illinois
- USA006 — Chicago
- USA001 — Chicago
New York
- USA102 — New York
Texas
- USA016 — Dallas
Buenos Aires
- ARG009 — Quilmes
Santa Fe Province
- ARG006 — Rosario
Tucumán Province
- ARG007 — San Miguel de Tucumán
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2023-03-07 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05649748
The ClinicalTrials.gov registry entry for NCT05649748 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insmed Incorporated, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05649748 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05649748 about?
NCT05649748 is a clinical study titled "An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)". The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.
What is the current status of trial NCT05649748?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2023-03-07. Estimated completion is 2026-12-31.
What conditions does trial NCT05649748 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05649748?
The interventions under investigation include: Placebo (DRUG), Treprostinil Palmitil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05649748?
This trial is sponsored by Insmed Incorporated, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05649748 being conducted?
This trial has 20 study locations across Florida, Illinois, New York, Texas, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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