EUCTR2004-000625-30-ESActive, not recruitingPhase 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 sites0 target enrollmentStarted: September 16, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •4. Signed IRB/IEC approved informed consent (and assent if applicable).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
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 +).
Investigators
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