An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Condition(s) studied
Investigational drug(s) / intervention(s)
Treprostinil Palmitil: Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.
Placebo: Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler
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.
Eligibility
Primary outcome measure(s)
- 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)
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| USA005 | Jacksonville | Florida | |
| USA011 | Tampa | Florida | |
| USA006 | Chicago | Illinois | |
| USA001 | Chicago | Illinois | |
| USA102 | New York | New York | |
| USA016 | Dallas | Texas | |
| ARG009 | Quilmes | Buenos Aires | |
| ARG006 | Rosario | Santa Fe Province | |
| ARG007 | San Miguel de Tucumán | Tucumán Province | |
| ARG004 | Córdoba | Argentina | |
| ARG001 | Córdoba | Argentina | |
| AUT002 | Linz | Upper Austria | |
| AUT001 | Vienna | Austria | |
| BEL003 | Brussels | Belgium | |
| BRA004 | Belo Horizonte | Minas Gerais | |
| BRA006 | Porto Alegre | Rio Grande do Sul | |
| BRA002 | Blumenau | Santa Catarina | |
| DNK001 | Aarhus | Central Jutland | |
| GER005 | Heidelberg | Baden-Wurttemberg | |
| GER003 | München | Bavaria | |
| GER002 | Lübeck | Schleswig-Holstein | |
| ITA002 | Pavia | Lombardy | |
| ITA005 | Monza | Italy | |
| ITA001 | Palermo | Italy | |
| ITA004 | Roma | Italy | |
| JPN005 | Sapporo | Hokkaido | |
| JPN004 | Sapporo | Hokkaido | |
| JPN007 | Kurume-shi | Hukuoka | |
| JPN006 | Tsukuba | Ibaraki | |
| JPN002 | Okayama | Okayama-ken | |
| JPN003 | Suita-Shi | Osaka | |
| MYS005 | Alor Star | Kedah | |
| MYS002 | Kuantan | Pahang | |
| MYS004 | Sungai Buloh | Selangor | |
| MEX005 | Lomas de Guevara | Jalisco | |
| MEX001 | Monterrey | Nuevo León | |
| MEX003 | Mexico City | Mexico | |
| MEX004 | San Luis Potosí City | Mexico | |
| PHL001 | Quezon City | National Capital Region | |
| PHL002 | Makati City | Philippines |
+ 5 more sites — see the full list on the official registry below.
More Insmed Incorporated trials in Mexico
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05649748 on ClinicalTrials.gov ↗ ← All trials in Mexico