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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01092559 |
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Date of registration:
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16/02/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
PILOT |
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Scientific title:
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An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01092559 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have a confirmed diagnosis of PAH, WHO Group 1.
- WHO Functional Class II or III equivalent, PAH.
- Have been clinically stable with regard to signs and symptoms of PAH for at least 30
days prior to RHC.
- May be receiving approved mono therapies or combination PAH therapies.
- Females that are surgically sterile or post-menopausal. Females of chil-bearing
potential must have negative pregnancy test and must be practicing adequate birth
control.
Exclusion Criteria:
- Have had a new type of chronic therapy (including but not limited to oxygen, a
different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month
of RHC.
- Have any PAH medication except for anticoagulants discontinued within the week prior
to RHC.
- Have evidence of significant parenchymal lung disease as evidenced by pulmonary
function tests within the last six months
- CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly,
telangiectasia) syndrome
- Have a history of uncontrolled sleep apnea within three months of RHC.
- Have a history of hemodynamically significant left-sided heart disease
- Have evidence of left-sided heart disease
- Have any other disease that is associated with pulmonary hypertension (e.g. congenital
systemic-to-pulmonary shunt, sickle cell anemia, schistosomiasis).
- Documented uncontrolled systemic hypertension as evidenced by systolic blood pressure
greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- Have used prescription appetite suppressants within 3 months prior to wean/transition.
- Have chronic kidney disease stage IV or worse or the requirement for dialysis.
- Be receiving an investigational drug, have in place an investigational device, or have
participated in an investigational drug study within the past 30 days.
- Have had an atrial septostomy.
- Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition
that would interfere with the interpretation of study assessments.
- Have any serious or life-threatening disease other than conditions associated with PAH
(e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
- Have unstable psychiatric status or be mentally incapable of understanding the
objectives, nature or consequences of the trial
- Participant is pregnant or lactating
- Significant, ongoing alcohol or drug abuse.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system
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Primary Outcome(s)
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Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.
[Time Frame: through Day 30 Follow-up Period]
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Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation
[Time Frame: through Treatment Period]
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Secondary ID(s)
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P2010-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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