EUCTR2004-000625-30-GB
Active, not recruiting
Phase 1
Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing - N/A
INO Therapeutics0 sites150 target enrollmentFebruary 10, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- itric Oxide for inhalation at 800ppm, plus 100% O2, to be used to assess pulmonary vaso reactivity during Pulmonary Vasodilator Testing
- Sponsor
- INO Therapeutics
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient must meet the following criteria:
- •1\. Have any one of the three disease categories:
- •a. Idiopathic Pulmonary Arterial Hypertension
- •i. PAPm › 25mmHg at rest, PCWP \= 15mmHg, and PVRI › 3 u· m2 or diagnosed clinically with no previous catheterization.
- •b. CHD with pulmonary hypertension repaired and unrepaired,
- •i. PAPm › 25mmHg at rest, and PVRI › 3 u· m2 or diagnosed clinically with no previous catheterization
- •c. Cardiomyopathy
- •i. PAPm › 25mmHg at rest, and PVRI › 3 u•m2 or diagnosed clinically with no previous catheterization.
- •2\. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
- •3\. Males or females, ages 4 weeks to 18 years, inclusive
Exclusion Criteria
- •The patient will be excluded from enrolment if any of the following are true:
- •1\. Focal pulmonary infiltrates on chest radiograph.
- •2\. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient’s pulmonary hypertension.
- •3\. Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, or are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other PDE\-5 inhibitors, or prostacyclin.
- •4\. Pregnant (urine HCG \+).
- •5\. Baseline PCWP \> 20 mmHG.
Outcomes
Primary Outcomes
Not specified
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