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ClinicalTrials.gov record
Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01457781

Public ClinicalTrials.gov record NCT01457781. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 24, 2026, 5:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT01457781
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bellerophon Pulse Technologies
Industry
Enrollment
80 participants

Conditions and interventions

Interventions

  • Inhaled Nitric Oxide 0.025 mg/kg IBW/hr delivered via INOpulse DS Device Combination Product
  • Placebo delivered via INOpulse DS Device Combination Product
  • Inhaled nitric oxide 0.075 mg/kg IBW/hr delivered via INOpulse DS Device Combination Product

Combination Product

Eligibility (public fields only)

Age range
16 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2012
Primary completion
Sep 30, 2014
Completion
Jun 30, 2016
Last update posted
Feb 26, 2023

2012 – 2016

United States locations

U.S. sites
47
U.S. states
29
U.S. cities
41
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294-0006
Arizona Pulmonary Specialists Phoenix Arizona 85012
Allianz Research Institute, Inc. Fountain Valley California 92708
University of California, San Francisco-Fresno Fresno California 93721
West Los Angeles VA Healthcare Center Los Angeles California 90073
David Geffen School of Medicine at UCLA Los Angeles California 90095
Los Angeles Biomedical Research Institute at Harbor-UCLA Med Ctr Torrance California 90509
Children's Hospital Colorado Aurora Colorado 80045
University of Colorado Denver Aurora Colorado 80045
South Denver Cardiology Associates P.C. Littleton Colorado 80120
Christiana Care Health System Newark Delaware 19713
University of Florida College of Medicine Jacksonville Florida 32209
Cleveland Clinic Florida Weston Florida 33331
Emory University Hospital-Emory Clinic Atlanta Georgia 30322
University of Iowa Hospitals & Clinics Iowa City Iowa 52242
University of Kansas Medical Center Kansas City Kansas 66160
University of Kentucky Gill Heart Lexington Kentucky 40536
Kentuckiana Pulmonary Associates Louisville Kentucky 40202
LSUHSC-New Orleans New Orleans Louisiana 70112
University of Maryland Medical Center Baltimore Maryland 21201
Tufts Medical Center Boston Massachusetts 02111
Boston University Medical Center/Boston University School of Medicine Boston Massachusetts 02118-2526
University of Michigan Ann Arbor Michigan 48109
University of Minnesota, Cardiovascular Division Minneapolis Minnesota 55455
Mayo Clinic Rochester Minnesota 55905
Washington University School of Medicine St Louis Missouri 63110
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756
University of Medicine and Dentistry of NJ Newark New Jersey 07103
Barnabas Health Newark Beth Israel Medical Center Newark New Jersey 07112
Beth Israel Medical Center New York New York 10003
Weill Cornell Medical Center New York New York 10021
Montefiore Medical Center The Bronx New York 10461
Duke University Medical Center Durham North Carolina 27710
UC Health/University of Cincinnati Cincinnati Ohio 45267
University Hospitals Case Medical Center Cleveland Ohio 44106
Cleveland Clinic Cleveland Ohio 44195
Ohio State University Martha Morehouse Medical Pavillion Columbus Ohio 43221
South Oklahoma Heart Research LLC Oklahoma City Oklahoma 73135
Legacy Medical Group - Pulmonary Clinic Portland Oregon 97210
Temple University Hospital Philadelphia Pennsylvania 19140
Allegheny Singer Research Institute/Allegheny General Hospital Pittsburgh Pennsylvania 15212
Rhode Island Hospital Providence Rhode Island 02903
Sioux Falls Cardiovascular PC Sioux Falls South Dakota 57108
University of Texas Southwestern Medical Center Dallas Texas 75390
Baylor College of Medicine Houston Texas 77030
Intermountain Medical Center Murray Utah 84157
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01457781, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2023 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01457781 live on ClinicalTrials.gov.

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