Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH



Status:Enrolling by invitation
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:March 2016
End Date:March 2018

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An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial
Hypertension (PAH)

An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in
subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and
to provide these patients with continued access to chronic iNO until the time of approval or
when the trial is discontinued due to lack of efficacy.

Inclusion Criteria:

- Signed Informed Consent Form prior to the initiation of any study mandated procedures
or assessments.

- PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 study and have
continued drug/device usage until EOS.

- Subjects are willing and considered in the judgement of the Investigator able to use
the INOpulse device for up to 24 hours per day and could benefit from continued use.

- All female subjects must be willing to continue to take adequate precaution to avoid
pregnancy by using suitable methods of birth control.

Exclusion Criteria:

- Subjects who require treatment with riociguat

- Subjects who early discontinued drug/device usage due to withdrawal of consent or an
AE requiring termination from treatment in IK-7001-PAH-201
We found this trial at
13
sites
Los Angeles, California 90073
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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Calgary, Alberta
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Cincinnati, OH
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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New York, New York 10003
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, PA
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