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Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)

NCT01457781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-27

No results posted yet for this study

Summary

This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-on Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).

Conditions

Interventions

COMBINATION_PRODUCT

Inhaled Nitric Oxide 0.025 mg/kg IBW/hr delivered via INOpulse DS Device

Cohort 1: 0.025 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (3.0 mg/L \[2440 ppm\] NO mini-cylinder; change q 24 hours) delivered via INOpulse DS Device and INOpulse DS nasal cannula

COMBINATION_PRODUCT

Placebo delivered via INOpulse DS Device

Placebo 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (Nitrogen N2, 99.999%) delivered via INOpulse DS Device and INOpulse DS nasal cannula

COMBINATION_PRODUCT

Inhaled nitric oxide 0.075 mg/kg IBW/hr delivered via INOpulse DS Device

Cohort 2: 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (6.0 mg/L \[4880 ppm\] NO mini-cylinder; change q 24 hours) delivered via INOpulse DS Device and INOpulse DS nasal cannula

Sponsors & Collaborators

  • Bellerophon Pulse Technologies

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed, MD · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-10-31
Completion
2016-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457781 on ClinicalTrials.gov