NCT00323024

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 30, 2007

Status Verified

July 1, 2006

First QC Date

May 5, 2006

Last Update Submit

August 29, 2007

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Arterial HypertensionPulmonary HypertensionIdiopathic PAHPH 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)

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

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

Interventions

NX1011DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85013, United States

Location

University of California, San Diego Medical Center

La Jolla, California, 92037, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Victoria A Christian

    NITROX, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 9, 2006

Study Start

September 1, 2006

Study Completion

May 1, 2007

Last Updated

August 30, 2007

Record last verified: 2006-07

Locations

US(6)