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

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO Therapy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02652429

Enrollment

Registered

2016-01-11

Start date

2016-03-31

Completion date

2023-12-31

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO

Brief summary

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

Detailed description

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.

Interventions

DRUGInhaled Nitric Oxide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open Label Extension

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Serious Adverse Events	Through Study Completion, anticipated 3 years	Incidence of Serious Adverse Events from baseline to end of study
Incidence of INOpulse device malfunction and/or device failure leading to an AE	Through Study Completion, anticipated 3 years	Incidence of INOpulse device malfunction and/or device failure leading to an AE from baseline to end of study

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026