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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
NITROX, LLC
ClinicalTrials.gov Identifier:
NCT00323024
First received: May 5, 2006
Last updated: August 29, 2007
Last verified: July 2006

May 5, 2006
August 29, 2007
September 2006
Not Provided
  • To evaluate the safety, tolerability, and activity of inhalation therapy with NX1011 based on right heart catheterization (RHC) measures, pulse oximetry, and hemodynamic response
  • To establish maximum tolerated dose (MTD) levels of NX1011 based on predefined criteria for dose-limiting toxicity (DLT)
  • To qualify the delivery apparatus
  • 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
  • To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy
  • To evaluate the safety, tolerability, and activity of inhalation therapy with ethyl nitrite (ENO) based on RHC measures, pulse oximetry, and hemodynamic response
  • To establish maximum tolerated dose (MTD) levels of ENO based on predefined criteria for dose-limiting toxicity (DLT)
  • To qualify the delivery apparatus
  • 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-on, fixed-dose, placebo-controlled study
  • To summarize correlation data between echocardiography and RHC measures with respect to activity
  • To summarize correlation data between methemoglobin levels documented using blood gas measurements (co-oximetry) and continuous methemoglobin monitoring documented via the visible light spectroscopy device
Complete list of historical versions of study NCT00323024 on ClinicalTrials.gov Archive Site
To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy
Not Provided
Not Provided
Not Provided
 
Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension
An Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial Hypertension

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: NX1011
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
72
May 2007
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00323024
NX1011:201
Not Provided
Not Provided
NITROX, LLC
Not Provided
Study Director: Victoria A Christian NITROX, LLC
NITROX, LLC
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP