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Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

NCT00626028 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2019-12-20

Study results available
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Summary

The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

Conditions

Interventions

DRUG

Nitric Oxide for inhalation

Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system

DRUG

Oxygen

100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system

DRUG

Nitric Oxide plus Oxygen

Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2010-02-28
Completion
2010-02-28
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • Spain
  • United Kingdom

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 NCT00626028 on ClinicalTrials.gov