An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension

Conditions

Pulmonary Arterial Hypertension

Brief summary

Frequency and severity of TEAEs during the study

Detailed description

Change from pre-OLE baseline to Month 6, Month 12, Month 18, and Month 24 in 6MWD (absolute and relative), in the concentration of NT proBNP in blood, in the REVEAL Lite 2.0 score, in NYHA/WHO functional capacity class., Annualized rate of clinical worsening events defined as 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 a 20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure. Annualized clinical worsening event rate 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., Plasma concentration levels of TP and TRE

Related papers

No related papers found yet.

Interventions

DRUGTREPROSTINIL PALMITIL INHALATION POWDER

DRUGPlacebo (inhalation powder capsules) containing 1 of 3 dosage strengths of TPIP (80 μg

DRUG160 μg

DRUGor 320 μg)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency and severity of TEAEs during the study	—

Secondary

Measure	Time frame
Change from pre-OLE baseline to Month 6, Month 12, Month 18, and Month 24 in 6MWD (absolute and relative), in the concentration of NT proBNP in blood, in the REVEAL Lite 2.0 score, in NYHA/WHO functional capacity class., Annualized rate of clinical worsening events defined as 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 a 20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure. Annualized clinical worsening event rate 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., Pla	—

Measure

Time frame

Change from pre-OLE baseline to Month 6, Month 12, Month 18, and Month 24 in 6MWD (absolute and relative), in the concentration of NT proBNP in blood, in the REVEAL Lite 2.0 score, in NYHA/WHO functional capacity class., Annualized rate of clinical worsening events defined as 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 a 20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure. Annualized clinical worsening event rate 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., Pla

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Countries

Austria, Belgium, Denmark, Germany, Italy, Spain

Outcome results

None listed