Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
709 participants
INTERVENTIONAL
2010-07-07
2021-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
ACT-293987, twice daily
ACT-293987
Tablets, twice daily
Interventions
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ACT-293987
Tablets, twice daily
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Aline Frey
Role: STUDY_DIRECTOR
Actelion
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Torrance, California, United States
Newark, Delaware, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Austell, Georgia, United States
Carmel, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Troy, Michigan, United States
Rochester, Minnesota, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Islandia, New York, United States
New York, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Bend, Oregon, United States
Portland, Oregon, United States
Doylestown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
York, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
Adelaide, , Australia
Bedford Park, , Australia
Chermside, , Australia
Concord, , Australia
Darlinghurst, , Australia
Fitzroy, , Australia
Hobart, , Australia
Murdoch, , Australia
New Lambton, , Australia
Parkville, , Australia
Graz, , Austria
Vienna, , Austria
Minsk, , Belarus
Brussels, , Belgium
Leuven, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Santiago, , Chile
Beijing, , China
Guangzhou, , China
Shanghai, , China
Bogotá, , Colombia
Prague, , Czechia
Aarhus, , Denmark
Copenhagen, , Denmark
Bron, , France
Le Kremlin-Bicêtre, , France
Lille, , France
Toulouse, , France
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Giessen, , Germany
Greifswald, , Germany
Hanover, , Germany
Heidelberg, , Germany
Leipzig, , Germany
Löwenstein, , Germany
Regensburg, , Germany
Alexandroupoli, , Greece
Athens, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Ahmedabad, , India
Chennai, , India
Hyderabad, , India
Dublin, , Ireland
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Kuala Lumpur, , Malaysia
Mexico City, , Mexico
Amsterdam, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Lima, , Peru
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Otwock, , Poland
Bucharest, , Romania
Iași, , Romania
Barnaul, , Russia
Kemerovo, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Singapore, , Singapore
Bratislava, , Slovakia
Košice, , Slovakia
Incheon, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Madrid, , Spain
Gothenburg, , Sweden
Linköping, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Khon Kaen, , Thailand
Adana, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Glasgow, , United Kingdom
London, , United Kingdom
Countries
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References
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Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2009-014992-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AC-065A303
Identifier Type: -
Identifier Source: org_study_id
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