IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH)

Conditions

Pulmonary Arterial Hypertension (PAH)

Brief summary

Primary Endpoint (Phase 2b): Placebo corrected change from baseline at Week 24 in PVR, Primary Endpoint (Phase 3): Placebo corrected change from baseline at Week 24 in the 6MWD

Detailed description

Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in NT-proBNP, Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in 6MWD, Secondary Endpoint (Phase 2b): Incidence of Clinical Worsening events, Secondary Endpoint (Phase 2b): Improvement at Week 24 in WHO Functional Class, Secondary Endpoint (Phase 2b): Change in REVEAL Lite 2.0 risk score, Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in QoL, Secondary Endpoint (Phase 3): Change from baseline at Week 24 in NT-proBNP, Secondary Endpoint (Phase 3): Time to Clinical Worsening events, Secondary Endpoint (Phase 3): Improvement at Week 24 in WHO Functional Class, Secondary Endpoint (Phase 3): Change in REVEAL Lite 2.0 risk score, Secondary Endpoint (Phase 3): Change from baseline at Week 24 in QoL

Related papers

No related papers found yet.

Interventions

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary Endpoint (Phase 2b): Placebo corrected change from baseline at Week 24 in PVR, Primary Endpoint (Phase 3): Placebo corrected change from baseline at Week 24 in the 6MWD	—

Secondary

Measure	Time frame
Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in NT-proBNP, Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in 6MWD, Secondary Endpoint (Phase 2b): Incidence of Clinical Worsening events, Secondary Endpoint (Phase 2b): Improvement at Week 24 in WHO Functional Class, Secondary Endpoint (Phase 2b): Change in REVEAL Lite 2.0 risk score, Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in QoL, Secondary Endpoint (Phase 3): Change from baseline at Week 24 in NT-proBNP, Secondary Endpoint (Phase 3): Time to Clinical Worsening events, Secondary Endpoint (Phase 3): Improvement at Week 24 in WHO Functional Class, Secondary Endpoint (Phase 3): Change in REVEAL Lite 2.0 risk score, Secondary Endpoint (Phase 3): Change from baseline at Week 24 in QoL	—

Measure

Time frame

Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in NT-proBNP, Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in 6MWD, Secondary Endpoint (Phase 2b): Incidence of Clinical Worsening events, Secondary Endpoint (Phase 2b): Improvement at Week 24 in WHO Functional Class, Secondary Endpoint (Phase 2b): Change in REVEAL Lite 2.0 risk score, Secondary Endpoint (Phase 2b): Change from baseline at Week 24 in QoL, Secondary Endpoint (Phase 3): Change from baseline at Week 24 in NT-proBNP, Secondary Endpoint (Phase 3): Time to Clinical Worsening events, Secondary Endpoint (Phase 3): Improvement at Week 24 in WHO Functional Class, Secondary Endpoint (Phase 3): Change in REVEAL Lite 2.0 risk score, Secondary Endpoint (Phase 3): Change from baseline at Week 24 in QoL

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Countries

Austria, Belgium, Czechia, France, Germany, Greece, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed