Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide
| Status: | Withdrawn |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | August 2015 |
A Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension
The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of
GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation
predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health
Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically
necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo
an attempt to wean from parenteral PGI per standard of care.
GeNOsyl(R) delivery system(s) to evaluate if inhaled nitric oxide-induced vasodilation
predicts successful wean from parenteral prostacyclin (PGI) in subjects with World Health
Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) undergoing a medically
necessary right heart catheterization (RHC). All subjects enrolled in the study will undergo
an attempt to wean from parenteral PGI per standard of care.
This study will be divided into 2 parts: a Pilot Phase followed by Pivotal Phase.
- The Pilot Phase will enroll up to 20 subjects. The information derived from the Pilot
Phase will evaluate safety, and assess the vasoreactivity test response rate.
- Approximately 150 subjects will be enrolled in the Pivotal Phase of the study, to
gather further data on weaned successes from parenteral PGI. The Investigator and study
staff involved with the wean and patient management will be blinded in this phase of
the study to the vasoreactivity results.
- The Pilot Phase will enroll up to 20 subjects. The information derived from the Pilot
Phase will evaluate safety, and assess the vasoreactivity test response rate.
- Approximately 150 subjects will be enrolled in the Pivotal Phase of the study, to
gather further data on weaned successes from parenteral PGI. The Investigator and study
staff involved with the wean and patient management will be blinded in this phase of
the study to the vasoreactivity results.
Inclusion Criteria:
- The subject or subject's legally authorized representative signs and dates an
Institutional Review Board (IRB) approved informed consent form prior to the
initiation of any study-related activities.
- The subject has been diagnosed with PAH (WHO Group 1) and is WHO Functional Class I
or II at Screening.
- The subject has documented continuous PGI use for ≥ 1 year from Screening, without a
significant interruption (i.e., ≤ 2 day interruption) and without a failed complete
wean attempt.
- The subject is a candidate for weaning off parenteral PGI therapy (per Investigator
judgment and standard of care).
Exclusion Criteria
- The subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide
or other clinically significant allergies (clinical significance per Investigator
judgment).
- The subject has a PCWP or left ventricular end diastolic pressure (LVEDP) ≥15 mmHg at
Baseline.
- The subject has participated in an investigational product or device study within the
30 days prior to Screening.
We found this trial at
2
sites
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