Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
About the study
IMPAHCT-FUL: Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial was a follow up study to establish the long-term safety of AV-101. Subjects who successfully completed the 24-week placebo-controlled parent trial (AV-101-002, NCT#05036135) were offered the opportunity to continue into this LTE study. Subjects who enrolled in the study were to receive one of three active AV-101 doses until such time as the optimal dose was selected in the parent study.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
To be eligible, a participant is required to be or have:
* Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.
EXCLUSION CRITERIA
Key Exclusion Criteria:
Subjects meeting any of the following criteria:
- The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
- Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Pulmonary Arterial Hypertension
Age (in years)
18 - 75
Phase
PHASE3
Participants Needed
186
Est. Completion Date
Aug 8, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Aerovate Therapeutics
ClinicalTrials.gov NCT Identifier
NCT05557942
Study Number
AV-101-003
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