Selexipag (ACT-293987) in Pulmonary Arterial Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:1/13/2018
Start Date:December 1, 2009
End Date:October 1, 2014

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A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of
selexipag on time to first morbidity or mortality event in patients with pulmonary arterial
hypertension.


Inclusion Criteria:

- Male and female patients 18-75 years old, with symptomatic PAH

- PAH belonging to the following subgroups of the updated Dana Point Clinical
Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or
Associated (APAH) with Connective tissue disease, Congenital heart disease with simple
systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)

- Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at
any time prior to Screening

- Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior
to the Baseline Visit

- Signed informed consent

Exclusion Criteria:

- Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification
Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria

- Patients who have received prostacyclin or its analogs within 1 month before Baseline
Visit, or are scheduled to receive any of these compounds during the trial

- Patients with moderate or severe obstructive lung disease

- Patients with moderate or severe restrictive lung disease

- Patients with moderate or severe hepatic impairment (Child-Pugh B and C)

- Patients with documented left ventricular dysfunction

- Patients with severe renal insufficiency

- Patients with BMI <18.5 Kg/m2

- Patients who are receiving or have been receiving any investigational drugs within 1
month before the Baseline Visit

- Acute or chronic impairment (other than dyspnea), limiting the ability to comply with
study requirements, in particular with 6MWT

- Recently conducted or planned cardio-pulmonary rehabilitation program based on
exercise training

- Psychotic, addictive or other disorder limiting the ability to provide informed
consent or to comply with study requirements

- Life expectancy less than 12 months

- Females who are lactating or pregnant or plan to become pregnant during the study

- Known hypersensitivity to any of the excipients of the drug formulations
We found this trial at
43
sites
Louisville, Kentucky 40202
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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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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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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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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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Atlanta, GA
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1459 Laney-Walker Blvd
Augusta, Georgia 30901
(706) 721-3052
Georgia Health Sciences University Georgia Regents University, home of the Medical College of Georgia, is...
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Austell, Georgia 30106
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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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Buenos Aires,
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Carmel, Indiana 46032
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Cincinnati, Ohio 45219
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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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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Doylestown, Pennsylvania 18901
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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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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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La Jolla, CA
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Los Angeles, California 90073
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Milwaukee, Wisconsin 53215
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
University of South Alabama "University of South Alabama is a public institution that was founded...
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Nashville, Tennessee 37212
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New Orleans, Louisiana 70112
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Philadelphia, Pennsylvania
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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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Portland, Oregon 97225
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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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Torrance, California 90502
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44201 Dequindre Road
Troy, Michigan 48085
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