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

Sponsor

NITROX, LLC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00323024

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Sep 1, 2006

Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

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 []

Secondary Outcome Measures

To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Pulmonary Specialists, Ltd.	Phoenix	Arizona	United States	85013
2	University of California, San Diego Medical Center	La Jolla	California	United States	92037
3	Christiana Care Health Services	Newark	Delaware	United States	19718
4	University of Maryland	Baltimore	Maryland	United States	21201
5	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
6	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109