ACT-293987 in Pulmonary Arterial Hypertension



Status:Active, not recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:December 1, 2009
End Date:February 1, 2021

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Trial Summary
Trial Overview
Inclusion Criteria

Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the
safety and tolerability of ACT-293987 in patients with PAH who participated in the
double-blind study AC-065A302 (GRIPHON)


Inclusion Criteria:

- Patients who participated to the double-blind study AC-065A302 and either had a
morbidity event or had completed the study as scheduled per protocol.

- Signed informed consent.

Exclusion Criteria:

- Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin
analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in
AC-065A302/GRIPHON.

- Severe hepatic impairment (Child-Pugh C).

- Females who are pregnant or who plan to become pregnant during the study, or are
breastfeeding.

- Any known factor or disease that might interfere with treatment compliance, study
conduct or interpretation of the results, such as drug or alcohol dependence, or
psychiatric disease.
We found this trial at
36
sites
Johns Hopkins University School of Medicine
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Baltimore, MD
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Tufts Medical Center
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
Atlanta, Georgia 30322
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Atlanta, GA
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Georgia Regents Univ/ Augusta Univ
1430 John Wesley Gilbert Drive
Augusta, Georgia 30912
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Augusta, GA
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Piedmont Healthcare Pulm & Crit Care Research
3820 Medical Park Drive Southwest
Austell, Georgia 30106
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Austell, GA
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Boston University School of Medicine / Boston University Medical Center
Boston, Massachusetts 02118
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Boston, MA
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Montefiore Medical Center-Weiler Division
Bronx, New York 10461
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Bronx, NY
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Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Buenos Aires,
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Buenos Aires,
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The Lindner Clinical Trial Center
Cincinnati, Ohio 45219
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Cincinnati, OH
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Ohio State University Medical Center
Columbus, Ohio 43210
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Columbus, OH
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UT Southwestern Medical Center at Dallas
Dallas, Texas 75390
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Dallas, TX
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Henry Ford Hospital
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Duke Univ Med Ctr
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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University of Texas-Houston Health Center Department of Pulmonary & Critical Care
Houston, Texas 77030
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Houston, TX
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Baylor College of Medicine, Houston Methodist Hospital
6550 Fannin Street
Houston, Texas 77030
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Houston, TX
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University of California San Diego Medical Center (La Jolla)
La Jolla, California 92037
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La Jolla, CA
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GLVA Healthcare Center
Los Angeles, California 90073
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Los Angeles, CA
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Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
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Louisville, KY
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University of Wisconsin Hospital-Department of Medicine
Madison, Wisconsin 53792
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Madison, WI
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St. Luke's Medical Center
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Froedtert Hospital, Pulm & Critical Care
9200 West Wisconsin Avenue
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Vanderbilt Medical Center
Nashville, Tennessee 37212
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Nashville, TN
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LSU Health Science Center - New Orleans
New Orleans, Louisiana 70112
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New Orleans, LA
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Columbia University Medical Center, Pediatric Cardiology
New York, New York 10032
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New York, NY
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Christiana Care Health Services, Inc
Newark, Delaware 19713
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Newark, DE
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Newark Beth Israel Medical Center
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Newark, NJ
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Penn Presbyterian Medical Center
Philadelphia, Pennsylvania
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Philadelphia, PA
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Thomas Jefferson University Hospital
111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Oregon Pulmonary Associates, PC
Portland, Oregon 97225
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Portland, OR
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University of California, Davis, UC Davis Medical Center
Sacramento, California 95817
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Sacramento, CA
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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LIU Center for Pulmonary Hypertension
Torrance, California 90502
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Torrance, CA
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William Beaumont Hospital
Troy, Michigan 48085
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Troy, MI
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University of Arizona Clinical and Translational Science (CATS) Research Center
Tucson, Arizona 85724
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Tucson, AZ
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