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Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH

NCT02725372 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2023-02-21

Study results available
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Summary

Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

Conditions

Interventions

DRUG

Inhaled Nitric Oxide 75 mcg/kg IBW/hr

Inhaled Nitric Oxide 15mcg/Kg IBW/hr for two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period (Week 3 to Week 18)

DRUG

Placebo

Part 1 Placebo arm: Inhaled Nitric Oxide 15mcg/Kg IBW/hrfor two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Bellerophon Pulse Technologies

    lead INDUSTRY

Principal Investigators

  • Ashika Ahmed, MD · Bellerophon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Portugal
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02725372 on ClinicalTrials.gov