Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH
NCT ID: NCT02652429
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
22 participants
INTERVENTIONAL
2016-03-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inhaled Nitric Oxide (iNO)
Pulsed iNO 75 mcg/kg IBW/hour
Inhaled Nitric Oxide
Interventions
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Inhaled Nitric Oxide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
* Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
* All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
* Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.
Exclusion Criteria
* Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201
ALL
No
Sponsors
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Bellerophon Pulse Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Ashika Ahmed, MD
Role: STUDY_DIRECTOR
Bellerophon Therapeutics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mount Sinai Beth Israel
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
UC Health University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Fernando Torres, MD
Dallas, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Peter Lougheed Centre
Calgary, Alberta, Canada
University of Alberta Hospitals - MAHI
Edmonton, Alberta, Canada
Lawson Clinical Research Services
London, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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PULSE-PAH-006
Identifier Type: -
Identifier Source: org_study_id
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