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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000625-30 | EudraCT Number |
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The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide First, Oxygen Last | Experimental | 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. |
|
| Oxygen First, Nitric Oxide Last | Experimental | 10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide for inhalation | Drug | Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) | A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity) | on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Surgical Procedures Within 1 Year | Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment. | within 1 year |
| Number of Participants With Adverse Events (AEs) |
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Inclusion Criteria:
Must have any one of these three disease categories:
Idiopathic Pulmonary Arterial Hypertension
Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired
Cardiomyopathy
Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
Male or female, ages 4 weeks to 18 years, inclusive
Signed informed consent/assent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader, MD | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Salter Packard Children's Hospital at Stanford | Stanford | California | 94304 | United States | ||
| The Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20405117 | Derived | Barst RJ, Agnoletti G, Fraisse A, Baldassarre J, Wessel DL; NO Diagnostic Study Group. Vasodilator testing with nitric oxide and/or oxygen in pediatric pulmonary hypertension. Pediatr Cardiol. 2010 Jul;31(5):598-606. doi: 10.1007/s00246-010-9645-5. Epub 2010 Apr 20. |
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All 136 patients screened received all three study drugs in a crossover design, serving as their own controls. They were randomized 1:1 into two treatment sequences.
Children scheduled for clinically indicated right heart catheterization were screened for enrollment at 16 centers in the United States, United Kingdom, France, Spain and Netherlands.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitric Oxide First, Oxygen Last | 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. |
| FG001 | Oxygen First, Nitric Oxide Last |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Oxygen | Drug | 100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system |
|
| Nitric Oxide plus Oxygen | Drug | Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system |
|
|
An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity.
| on Day 1 |
| Number of Participants With Serious Adverse Events (SAEs) | SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs. | within 12 hours |
| Number of Participants With Related Surgical Procedures Within 3 Years | Number of participants who received surgery related to pulmonary or cardiac disease within 3 years | within 3 years |
| Denver |
| Colorado |
| 80218 |
| United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Columbus Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CHU Timone - Département de cardiologie | Marseille | France |
| Hôpital d'Enfants | Nancy | France |
| Hôpital NECKER - Enfants Malades | Paris | France |
| Beatrix Children's Hospital / University Hospital Groningen | Groningen | Netherlands |
| Hospital Sant Joan de Déu de Barcelona | Barcelona | Spain |
| Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón | Barcelona | Spain |
| Hospital Gregorio Maranon | Madrid | Spain |
| Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre | Madrid | Spain |
| Royal Brompton Hospital | London | United Kingdom |
| Southampton University Hospitals Trust - Wessex Cardiothoracic Centre | Southampton | United Kingdom |
10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.
| COMPLETED |
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| NOT COMPLETED |
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The intent-to-treat (ITT) population was defined as all participants randomized regardless of actual receipt of treatment gas, the treatment gas actually received, or the appropriateness of their enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitric Oxide First, Oxygen Last | 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. |
| BG001 | Oxygen First, Nitric Oxide Last | 10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) | A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity) | All participants in the intent to treat analysis set who completed the study | Posted | Count of Participants | Participants | on Day 1 |
|
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Related Surgical Procedures Within 1 Year | Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment. | All participants in the intent to treat analysis set who completed the study | Posted | Count of Participants | Participants | within 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity. | All participants in the intent to treat analysis set who completed the study | Posted | Count of Participants | Participants | on Day 1 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs. | Participants in the intent to treat analysis set who completed the study | Posted | Count of Participants | Participants | within 12 hours |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Related Surgical Procedures Within 3 Years | Number of participants who received surgery related to pulmonary or cardiac disease within 3 years | Participants in the intent to treat population who completed the study | Posted | Count of Participants | Participants | within 3 years |
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|
within 3 years
No non-serious adverse events reached the 5% reporting threshold
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitric Oxide First, Oxygen Last | 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. | 3 | 62 | 0 | 62 | ||
| EG001 | Oxygen First, Nitric Oxide Last | 10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1. | 0 | 59 | 0 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ST Segment Elevation | Investigations | MedDRA (7.0) | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (7.0) | Non-systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA (7.0) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (7.0) | Non-systematic Assessment |
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| Low Cardiac Output Syndrome | Cardiac disorders | MedDRA (7.0) | Non-systematic Assessment |
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| Decreased oxygen saturation | Investigations | MedDRA (7.1) | Non-systematic Assessment |
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Although the first and last treatments were randomly assigned, the second treatment was always the same. Therefore, a time/treatment interaction cannot be ruled out.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D065627 | Familial Primary Pulmonary Hypertension |
| D009202 | Cardiomyopathies |
| D055371 | Acute Lung Injury |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D055370 | Lung Injury |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D001239 | Inhalation |
| D045462 | Endothelium-Dependent Relaxing Factors |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018011 | Chalcogens |
| D004602 | Elements |
| D005740 | Gases |
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| >=65 years |
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| Male |
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| United States |
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| Spain |
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| Netherlands |
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| United Kingdom |
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