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Inhaled Imatinib for Pulmonary Arterial Hypertension (IMPAHCT-FUL Trial)

Phase 3
Recruiting
Research Sponsored by Aerovate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, anticipated to be approximately 3 years
Awards & highlights

IMPAHCT-FUL Trial Summary

This trial will study the long-term safety and effectiveness of a medicine, AV-101, for pulmonary arterial hypertension. Subjects will receive one of three doses until the optimal dose is found.

Who is the study for?
This trial is for people who have completed the initial 24-week study of AV-101 for Pulmonary Arterial Hypertension. They must consent to continue and be deemed suitable by the investigator, without social or clinical reasons that may interfere with their participation.Check my eligibility
What is being tested?
The IMPAHCT-FUL trial is testing long-term safety and effectiveness of different doses of an inhaled medication called AV-101 for treating Pulmonary Arterial Hypertension. Participants will receive one of three active doses determined optimal from a previous study.See study design
What are the potential side effects?
While specific side effects are not listed here, they could include typical reactions to pulmonary hypertension medications such as cough, headache, dizziness, nausea or potential respiratory issues due to inhalation.

IMPAHCT-FUL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, anticipated to be approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, anticipated to be approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of AV-101
Other outcome measures
Change from baseline in NT-proBNP
Echocardiography
Change from baseline in the 6MWD
+1 more

IMPAHCT-FUL Trial Design

3Treatment groups
Experimental Treatment
Group I: medium dose AV-101Experimental Treatment1 Intervention
Group II: low dose AV-101Experimental Treatment1 Intervention
Group III: high dose AV-101Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AV-101
2018
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Aerovate TherapeuticsLead Sponsor
1 Previous Clinical Trials
462 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
462 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

low dose AV-101 Clinical Trial Eligibility Overview. Trial Name: NCT05557942 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: low dose AV-101, medium dose AV-101, high dose AV-101
Pulmonary Arterial Hypertension Clinical Trial 2023: low dose AV-101 Highlights & Side Effects. Trial Name: NCT05557942 — Phase 3
low dose AV-101 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557942 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this research project for volunteers?

"Affirmative. According to the info hosted on clinicaltrials.gov, this medical trial is actively recruiting patients from a single site since its posting date of November 2nd 2022 and most recent edit made on December 6th 2022. Currently, 462 participants are desired for the research project."

Answered by AI

Does this research permit minors to participate?

"In order to meet the study's eligibility requirements, participants must have reached 18 years of age but not surpassed 75."

Answered by AI

What is the largest number of participants accepted into this clinical experiment?

"Affirmative. Clinicaltrials.gov data supports the notion that recruiting is currently being conducted for this research study, which was initially posted on November 2nd 2022 and latest modified December 6th 2022. The trial requires 462 participants to be enrolled from 1 medical centre."

Answered by AI

Is it possible for me to join this medical experiment?

"This clinical trial is recruiting 462 patients, who must meet the criteria of having pulmonary arterial hypertension and being between 18 to 75 years old."

Answered by AI
~262 spots leftby Dec 2025