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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02652429
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Bellerophon Pulse Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ashika Ahmed, MD
Principal Investigator Affiliation Bellerophon Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Arterial Hypertension
Additional Details

An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and PULSE-PAH-004 to provide these patients with continued access to chronic iNO until the time of approval or development of iNO in PAH is discontinued.

Arms & Interventions

Arms

Experimental: Inhaled Nitric Oxide (iNO)

Pulsed iNO 75 mcg/kg IBW/hour

Interventions

Drug: - Inhaled Nitric Oxide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

West Los Angeles VA Healthcare Center, Los Angeles, California

Status

Address

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073

University of Colorado Denver, Aurora, Colorado

Status

Address

University of Colorado Denver

Aurora, Colorado, 80045

Cleveland Clinic Florida, Weston, Florida

Status

Address

Cleveland Clinic Florida

Weston, Florida, 33331

University of Maryland Medical Center, Baltimore, Maryland

Status

Address

University of Maryland Medical Center

Baltimore, Maryland, 21201

Mount Sinai Beth Israel, New York, New York

Status

Address

Mount Sinai Beth Israel

New York, New York, 10003

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

UC Health University of Cincinnati, Cincinnati, Ohio

Status

Address

UC Health University of Cincinnati

Cincinnati, Ohio, 45267

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Columbus, Ohio

Status

Address

Ohio State University, Wexner Medical Center

Columbus, Ohio, 43221

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Fernando Torres, MD, Dallas, Texas

Status

Address

Fernando Torres, MD

Dallas, Texas, 75390

Intermountain Medical Center, Murray, Utah

Status

Address

Intermountain Medical Center

Murray, Utah, 84107

International Sites

Peter Lougheed Centre, Calgary, Alberta, Canada

Status

Address

Peter Lougheed Centre

Calgary, Alberta, T1Y6J4

University of Alberta Hospitals - MAHI, Edmonton, Alberta, Canada

Status

Address

University of Alberta Hospitals - MAHI

Edmonton, Alberta, T6G2B7

Lawson Clinical Research Services, London, Ontario, Canada

Status

Address

Lawson Clinical Research Services

London, Ontario, N6C2R5

University Health Network, Toronto, Ontario, Canada

Status

Address

University Health Network

Toronto, Ontario, M5G2C4

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