Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00323024
Recruitment Status : Withdrawn
First Posted : May 9, 2006
Last Update Posted : August 30, 2007
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Brief Summary:
The purpose of this study is to determine the safety and maximum tolerated dose of inhaled NX1011 for the treatment of pulmonary arterial hypertension (PAH).

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: NX1011 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial Hypertension
Study Start Date : September 2006
Study Completion Date : May 2007

Primary Outcome Measures :
  1. To evaluate the safety, tolerability, and activity of inhalation therapy with NX1011 based on right heart catheterization (RHC) measures, pulse oximetry, and hemodynamic response
  2. To establish maximum tolerated dose (MTD) levels of NX1011 based on predefined criteria for dose-limiting toxicity (DLT)
  3. To qualify the delivery apparatus
  4. To generate descriptive data on the concentration-response relationship in order to choose a range of concentrations (e.g., low, medium, high) for the follow-up, fixed-dose, placebo-controlled study
  5. To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy

Secondary Outcome Measures :
  1. To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must either:

    • meet the PAH diagnostic criteria at Screening (based on a documented history of diagnosis as outlined in the American College of Chest Physicians [ACCP] 2004 Evidence-Based Clinical Practices Guidelines)15; or
    • have elevated pulmonary pressure with a suspected PAH diagnosis based on a clinical referral at Screening for a RHC.
  • Patient must have PAH as defined by a mean pulmonary artery pressure (PAP) > 25 mmHg.
  • Patient must have symptoms of pulmonary hypertension (PH) according to the World Health Organization (WHO) Functional Classification of Pulmonary Hypertension Class II through IV.
  • Patient must consent to, be able to tolerate, and have adequate venous and arterial access for Swan-Ganz catheterization (SGC) and an arterial line.

Exclusion Criteria:

  • Clinically significant right-to-left intracardiac shunts based on Doppler echocardiography with bubble study.
  • History of pulmonary veno-occlusive disease or clinically significant aortic or mitral stenosis.
  • History of sustained ventricular tachycardia (VT-S) or ventricular fibrillation (VF) and cardiac arrest, or presence of atrial fibrillation.
  • Active cardiac disease meeting the following criteria:

    • Patient with elevated pulmonary capillary wedge pressures (PCWPs) > 25 mmHg.
    • Patient with a history of myocardial infarction or coronary intervention within the last 60 days.
    • Patient with a history of pacemaker, cardiac defibrillator, or biventricular pacemaker insertion within 4 weeks of Baseline.
    • Patient who cannot be withdrawn from nitrate therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00323024

United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States, 85013
United States, California
University of California, San Diego Medical Center
La Jolla, California, United States, 92037
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Study Director: Victoria A Christian NITROX, LLC Identifier: NCT00323024     History of Changes
Other Study ID Numbers: NX1011:201
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: August 30, 2007
Last Verified: July 2006

Keywords provided by NITROX, LLC:
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Idiopathic PAH
PH associated with connective tissue disease (CTD)
PH associated with interstitial lung disease (ILD)
PH associated with congestive heart failure (CHF)
PH associated with chronic obstructive pulmonary disease (COPD)

Additional relevant MeSH terms:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases