Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

Status unconfirmed · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)

Key facts

Study ID

NCT02652429

Run by

Bellerophon Pulse Technologies

People needed

22

Starts

2016-03-01

Expected to finish

2023-12-01

Last updated by the study team

2023-02-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
• 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.

You may not qualify if…

• Subjects who require treatment with riociguat
• Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201

Where it is running

• 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

Full record on ClinicalTrials.gov

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