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

NCT ID: NCT00323024

Last Updated: 2007-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-05-31

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).

Conditions

Pulmonary Hypertension

Keywords

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

NX1011

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NITROX, LLC

INDUSTRY

Sponsor Role: lead

Principal Investigators

Victoria A Christian

Role: STUDY_DIRECTOR

NITROX, LLC

Locations

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, United States

University of California, San Diego Medical Center

La Jolla, California, United States

Christiana Care Health Services

Newark, Delaware, United States

University of Maryland

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

NX1011:201

Identifier Type: -

Identifier Source: org_study_id