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Vasodilator

Inhaled Nitric Oxide for PAH

Phase 3

Waitlist Available

Research Sponsored by Bellerophon Pulse Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, anticipated 3 years

Awards & highlights

Study Summary

This trial is testing the long-term safety of inhaled nitric oxide for people with pulmonary arterial hypertension.

Eligible Conditions

Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, anticipated 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, anticipated 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, anticipated 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

Medical Devices

Incidence of Serious Adverse Events

Side effects data

From 2014 Phase 3 trial • 451 Patients • NCT00931632

29%

Hyponatraemia

15%

Patent ductus arteriosus

13%

Bronchopulmonary dysplasia

13%

Metabolic acidosis

11%

Sepsis

Hyperglycemia

Pulmonary edema

Necrotising enterocolitis neonatal

Feeding disorder neonatal

Atelectasis

Staphylococcal sepsis

Intestinal perforation

Hypotension

Pneumothorax

Anemia neonatal

Abdominal distension

Urinary tract infection

Fungal sepsis

Group B streptococcus neonatal sepsis

Pneumonia bacterial

Intraventricular hemorrhage neonatal

Pneumonia

Hydrocephalus

Infantile apnoeic attack

Thrombocytopenia

Septic shock

100%

80%

60%

40%

20%

Study treatment Arm

Inhaled Nitric Oxide

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Inhaled Nitric Oxide (iNO)Experimental Treatment1 Intervention

Pulsed iNO 75 mcg/kg IBW/hour

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inhaled Nitric Oxide

2011

Completed Phase 3

~780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bellerophon Pulse TechnologiesLead Sponsor

6 Previous Clinical Trials

782 Total Patients Enrolled

3 Trials studying Pulmonary Arterial Hypertension

287 Patients Enrolled for Pulmonary Arterial Hypertension

Ashika Ahmed, MDStudy DirectorBellerophon Therapeutics

10 Previous Clinical Trials

1,032 Total Patients Enrolled

3 Trials studying Pulmonary Arterial Hypertension

287 Patients Enrolled for Pulmonary Arterial Hypertension

Hunter Gilles, MDStudy DirectorBellerophon Therapuetics

1 Previous Clinical Trials

Media Library

Inhaled Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT02652429 — Phase 3

Pulmonary Arterial Hypertension Research Study Groups: Inhaled Nitric Oxide (iNO)

Pulmonary Arterial Hypertension Clinical Trial 2023: Inhaled Nitric Oxide Highlights & Side Effects. Trial Name: NCT02652429 — Phase 3

Inhaled Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02652429 — Phase 3

Frequently Asked Questions

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

Could you please list the risks associated with Inhaled Nitric Oxide?

"Because there is both efficacy and safety data from multiple rounds of Phase 3 trials, Inhaled Nitric Oxide was given a safety score of 3."

Answered by AI

Is Inhaled Nitric Oxide a common treatment in other medical research?

"Inhaled Nitric Oxide was first studied in 2016 at the Cleveland Clinic. As of now, there are 68 completed studies and 20 clinical trials that are actively recruiting patients. A large number of these studies are based out of Birmingham, Alabama."

Answered by AI

Is this research being conducted in multiple locations within state?

"Currently, this trial is running at 17 sites, which include the University of Alabama at Birmingham in Birmingham, Peter Lougheed Centre in Calgary, and Allegheny General Hospital in Pittsburgh, among other locations."

Answered by AI

Are we enrolling patients in this research at this time?

"Currently, this clinical trial is not looking for new participants. The study was first posted on March 1st, 2016 and was updated on August 9th, 2020. There are 779 other trials actively recruiting patients with pulmonary arterial hypertension and 20 for Inhaled Nitric Oxide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02652429.