NCT02652429

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Bellerophon Pulse Technologies · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide

Timeline

• Start date: 2016-03-01
• Primary completion: 2023-04-01
• Completion: 2023-12-01
• First posted: 2016-01-11
• Last updated: 2023-02-21

Locations

17 sites across 2 countries: United States, Canada