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

Pulmonary Hypertension Clinical Trial

Official title:

An Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00323024
• Other study ID #: NX1011:201
• Status: Withdrawn
• Phase: Phase 2
• First received: May 5, 2006
• Last updated: August 29, 2007
• Start date: September 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2006
• Source: NITROX, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 72
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• NX1011

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of California, San Diego Medical Center	La Jolla	California
United States	Christiana Care Health Services	Newark	Delaware
United States	Arizona Pulmonary Specialists, Ltd.	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
NITROX, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability, and activity of inhalation therapy with NX1011 based on right heart catheterization (RHC) measures, pulse oximetry, and hemodynamic response
Primary	To establish maximum tolerated dose (MTD) levels of NX1011 based on predefined criteria for dose-limiting toxicity (DLT)
Primary	To qualify the delivery apparatus
Primary	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
Primary	To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy
Secondary	To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy