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Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

NCT05557942 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-10-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

AV-101

AV-101 (imatinib) administered via dry powder inhalation

Sponsors & Collaborators

  • Aerovate Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2024-08-08
Completion
2024-08-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • China
  • Colombia
  • France
  • Germany
  • Israel
  • Italy
  • Latvia
  • Mexico
  • Poland
  • Portugal
  • Singapore
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557942 on ClinicalTrials.gov