Pulmonary HypertensionPhase 2NCT00323024
Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension
A Phase 2 study testing NX1011 in people with Pulmonary Hypertension, run by NITROX, LLC at 6 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- NX1011
- How many people
- 72 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2006to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of California, San Diego Medical Center
La Jolla, California, 92037
Christiana Care Health Services
Newark, Delaware, 19718
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, 85013
About this study
Official title: 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).
- Conditions
- Pulmonary Hypertension
- Being tested
- NX1011
- 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)
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX1011Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startSep 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- NITROX, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Victoria A Christian, Study director, NITROX, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323024
- Sponsor's protocol ID
- NX1011:201
- Status last verified
- Jul 2006
- First submitted
- 5 May 2006
- Last updated
- 30 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00323024
- Acronym / sponsor ID
- NX1011:201
- 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)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 72 participants
- Lead sponsor
- NITROX, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- May 2007
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must either:
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NX1011 | Drug | – |
Primary outcome
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
1 secondary outcome
To summarize correlation data between echocardiography and RHC measures with respect to activity and methemoglobin levels documented via the visible light spectroscopy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria A Christian study director
NITROX, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NX1011 in people with Pulmonary Hypertension, run by NITROX, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety, tolerability, and activity of inhalation therapy with NX1011 based on right heart catheterization (RHC) measures, pulse oximetry, and hemodynamic response. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2007.