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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)
IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
University of Arizona, Department of Medicine
Tucson, Arizona, United States
UCLA/David Geffen School of Medicine-Pulmonary and Criticial Care
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center, Pulmonary & Critical Care
Los Angeles, California, United States
Dept of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of California
San Francisco, California, United States
LA Biomedical Research Institute Harbor
Torrance, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Start Date
December 2, 2021
Primary Completion Date
August 9, 2024
Completion Date
August 9, 2024
Last Updated
August 23, 2024
202
ACTUAL participants
AV-101
DRUG
Placebo
DRUG
Lead Sponsor
Aerovate Therapeutics
NCT07218029
NCT06649110
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06481852