Phase
Condition
Stress
Diabetes And Hypertension
Congestive Heart Failure
Treatment
Treprostinil Palmitil Inhalation Powder
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time oftheir completion of the lead-in study are eligible for enrolment within one year oftheir lead-in end of treatment visit.
Complete baseline screening assessments to confirm eligibility to participate ifmore than 30 days have elapsed since the end of the study visit in StudyINS1009-211, or any other lead-in PH-ILD TPIP study.
Capable of giving signed informed consent that includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.
Exclusion
Exclusion Criteria:
Participants who experienced any hypersensitivity or adverse drug reaction or werewithdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinionof the Investigator, could indicate that continued treatment with TPIP may presentan unreasonable risk for the participant.
Initiation of parenteral administration of prostacyclin analogues (eg, TRE,epoprostenol) since the completion of Study INS1009-211 or other TPIP studies.Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oralprostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag)are permitted if stopped 24 hours prior to the start of study drug administration.
Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
- Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
Study Design
Connect with a study center
ARG003
Autonomus City Of Buenos Aires, Buenos Aires C1280AEB
ArgentinaSite Not Available
ARG003
Autonomus City of Buenos Aires, Buenos Aires 3435907 C1280AEB
ArgentinaSite Not Available
ARG001
Rosario, Santa Fe S2013KDS
ArgentinaSite Not Available
ARG001
Rosario 3838583, Santa Fe Province 3836276 S2013KDS
ArgentinaSite Not Available
AUS005
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
AUS005
Macquarie Park 8347858, New South Wales 2155400 2109
AustraliaSite Not Available
BEL002
Liège, 4000
BelgiumSite Not Available
BEL002
Liège 2792413, 4000
BelgiumSite Not Available
GER006
Heidelberg 2907911, Baden-Wurttemberg 2953481 69126
GermanySite Not Available
GER006
Heidelberg, Baden-Württemberg 69126
GermanySite Not Available
GER004
München 2867713, Bavaria 2951839 81377
GermanySite Not Available
GER004
München, Bayern 81377
GermanySite Not Available
GER010
Giessen 2920512, Hesse 2905330 35392
GermanySite Not Available
GER010
Gießen, Hessen 35392
GermanySite Not Available
GER003
Essen, Nordrhein-Westfalen 45239
GermanySite Not Available
GER003
Essen 2928810, North Rhine-Westphalia 2861876 45239
GermanySite Not Available
GER001
Dresden, Sachsen 01307
GermanySite Not Available
GER001
Dresden 2935022, Saxony 2842566 01307
GermanySite Not Available
GER002
Berlin, 13125
GermanySite Not Available
GER012
Berlin, 14050
GermanySite Not Available
GER002
Berlin 2950159, 13125
GermanySite Not Available
GER012
Berlin 2950159, 14050
GermanySite Not Available
ITA004
Milan, Lombardia 20123
ItalySite Not Available
ITA002
Monza, Lombardia 20900
ItalySite Not Available
ITA004
Milan 3173435, Lombardy 3174618 20123
ItalySite Not Available
ITA002
Monza 3172629, Lombardy 3174618 20900
ItalySite Not Available
ITA001
Palermo, Sicilia 90127
ItalySite Not Available
ITA001
Palermo 2523920, Sicily 2523119 90127
ItalySite Not Available
ITA003
Napoli, 80131
ItalySite Not Available
ITA003
Napoli 9031661, 80131
ItalySite Not Available
ESP007
Oviedo, Asturias 33011
SpainSite Not Available
ESP003
Palma 2512989, Balearic Islands 2521383 07120
SpainSite Not Available
ESP009
Santiago de Compostela, Galicia 15706
SpainSite Not Available
ESP009
Santiago de Compostela 3109642, Galicia 3336902 15706
SpainSite Not Available
ESP003
Palma, Islas Baleares 07120
SpainSite Not Available
ESP007
Oviedo 3114711, Principality of Asturias 3114710 33011
SpainSite Not Available
ESP005
Barcelona, 08907
SpainSite Not Available
ESP010
Barcelona, 8035
SpainSite Not Available
ESP005
Barcelona 3128760, 08907
SpainSite Not Available
ESP010
Barcelona 3128760, 8035
SpainSite Not Available
GBR003
Clydebank, Glasgow G81 4DY
United KingdomSite Not Available
GBR003
Clydebank 2652730, Glasgow G81 4DY
United KingdomSite Not Available
GBR001
Sheffield, South Yorkshire S10 2JF
United KingdomSite Not Available
GBR001
Sheffield 2638077, South Yorkshire S10 2JF
United KingdomSite Not Available

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