CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 136 enrolled
Drug / intervention
Nitric Oxide for inhalation +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00626028
NCT00626028Phase 3Completed
CompareCT.gov

Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing

Mallinckrodt·interventional·Posted Feb 29, 2008·Updated Dec 20, 2019

In Brief

A Phase 3 clinical trial evaluating Nitric Oxide for inhalation, Oxygen, and 1 other intervention for Idiopathic Pulmonary Arterial Hypertension and Cardiomyopathy. Completed, enrolled 136 participants across 18 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
CountriesFrance, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 29, 2008
Enrollment StartSep 1, 2004
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.3 years ago

Interventions

Nitric Oxide for inhalationdrug

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

Oxygendrug

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

Nitric Oxide plus Oxygendrug

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