AzTrials
AzTrials

Pulmonary Arterial HypertensionPhase 3GRIPHONNCT01106014

Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

A Phase 3 study testing Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 182 sites in 39 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Selexipag
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,156 participants
Where
182 sitesin 39 countries
Study dates
1 Dec 2009to 1 Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

182 sites in 39 countries.

182 sites in 39 countries

United States43 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

    Atlanta, Georgia, 30322

  • Georgia Health Sciences University

    Augusta, Georgia, 30912-3135

  • Georgia Clinical Research

    Austell, Georgia, 30106

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital - Pulmonary Critical Care Unit

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital-Pulmonary Critical Care Unit

    Boston, Massachusetts, 02114

  • Boston University School of Medicine / Boston University Medical Center

    Boston, Massachusetts, 02118

  • Clarian North Hospital

    Carmel, Indiana, 46032

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219-2906

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University Medical Center

    Columbus, Ohio, 43221

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Central Bucks Specialists

    Doylestown, Pennsylvania, 18901

  • Duke University Medical Center

    Durham, North Carolina, 27710-0001

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas-Houston Health Center Department of Pulmonary & Critical Care

    Houston, Texas, 77030

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • University of California San Diego Medical Center (La Jolla)

    La Jolla, California, 92037

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • GLVA Healthcare Center

    Los Angeles, California, 90073

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital-Department of Medicine

    Madison, Wisconsin, 53792

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert Hospital - Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of South Alabama

    Mobile, Alabama, 36617

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232-2386

  • LSU Health Science Center - New Orleans

    New Orleans, Louisiana, 70112

  • Columbia University Medical Center, Pediatric Cardiology

    New York, New York, 10032

  • Lung Health & Sleep Emhancement Center, LLC

    Newark, Delaware, 19713

  • Newark Beth Isreal Medical Center-Department of Pulmonary Medicine

    Newark, New Jersey, 07112

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Oregon Pulmonary Associates, PC

    Portland, Oregon, 97225

  • University of California, Davis, UC Davis Medical Center

    Sacramento, California, 95817

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center, Weiler Division

    The Bronx, New York, 10461

  • LIU Center for Pulmonary Hypertension

    Torrance, California, 90502-2006

  • Beaumont Hospital

    Troy, Michigan, 48307

  • The University of Arizona, Clinical and Translational Science (CATS) Research Center

    Tucson, Arizona, 85704

Other trials in United States

Germany10 sites

  • DRK Kliniken Köpenick

    Berlin, 12559

  • "Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"

    Cologne, 50924

  • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13

    Dresden, 01307

  • "Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"

    Giessen, 35392

  • Universität Greifswald / Klinik für Innere Medizin B

    Greifswald, 17487

  • Medizinische Hochschule Hannover / Klinik für Pneumologie

    Hanover, 30625

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Praxis für Pneumologie und Allergologie

    Leipzig, 04103

  • Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie

    Löwenstein, 74245

  • Universitätsklinkum Regensburg / Innere Medizin II

    Regensburg, 93053

Other trials in Germany

Russia10 sites

  • Municipal Medical Institution City Hospital #5

    Barnaul, 656045

  • Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital

    Kemerovo, 650044

  • Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia

    Moscow, 105077

  • State Institution, "Institute fo Rheumatology of RAMS"

    Moscow, 115552

  • The Institution of the Clinical Cardiology named after A. L. Myaskinov

    Moscow, 121552

  • Limited liability company, Consultative diagnostic centre Healthy Joints

    Novosibirsk, 630091

  • V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex

    Saint Petersburg, 194156

  • Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department

    Tomsk, 634012

  • Tomsk Regional Clinical Hospital/ Pulmonology Unit

    Tomsk, 634063

  • Regional Clinical Hospital # 1

    Yekaterinburg, 620102

Other trials in Russia

Australia9 sites

  • Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)

    Adelaide, South Australia, 5000

  • Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology

    Bedford Park, South Australia, 5042

  • Prince Charles Hospital Lung Transplant, Thoracic Department

    Chermside, Queensland, 4032

  • St. Vincent's Hospital / Heart and Lung Transplant Unit

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Royal Hobart Hospital, Centre for Clinical Research

    Hobart, TAS 7000

  • John Hunter Hospital Autoimmune Resource and Research Centre

    New Lambton, 2305

  • Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine

    Parkville, VIC 3050

  • Royal Perth Hospital

    Perth, 6000

Other trials in Australia

Canada7 sites

  • University of Alberta Hospital - Children's Centre

    Edmonton, Alberta, T6G2C8

  • Hopital General Juif (Jewish General Hospital)

    Montreal, Quebec, H3T 1E2

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec, G1V 4G5

  • University Health Network

    Toronto, Ontario, M5G 2N2

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R8

Other trials in Canada

China7 sites

  • Peking Union Medical College Hospital, Rheumatology Department

    Beijing, 100032

  • Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center

    Beijing, 100037

  • Beijing Shijitan Hospital

    Beijing, 100038

  • Guangdong General Hospital, Cardiology Department

    Guangzhou, 510080

  • Renji Hospital, Rheumatology Department

    Shanghai, 200001

  • Renji Hospital, Cardiology Department

    Shanghai, 200127

  • Shanghai Pulmonary Hospital, Department of Pulmonary Circulation

    Shanghai, 200433

Other trials in China

Argentina6 sites

  • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

    Buenos Aires, C1119ACN

  • Sanatorio Otamendi y Miroli S.A.

    Buenos Aires, C1121ABL

  • Hospital Britanico-Pneumology

    Buenos Aires, C1280AEB

  • Sanatorio San Jose

    Buenos Aires, C1425DUH

  • Hospital Privado Centro Medico de Cordoba S.A.

    Córdoba, X5016KEH

  • Instituto De Cardiologia de Corrientes

    Corrientes, W3400AMZ

Other trials in Argentina

France6 sites

  • Hosp Pradel Lyon - Dpt Pneumology

    Bron, 69677

  • Hosp Cote de Nacre - Dpt Pneumology

    Caen, 14033

  • Hosp A. Beclere - Dept Pulmo & Resp Intensive Care

    Clamart, 92140

  • Hosp Huriez - Dpt Internal Medecine

    Lille, 59037

  • Hosp Civil - Dpt Pneumology

    Strasbourg, 67091

  • Hosp Larrey - Dpt Pneumology

    Toulouse, 31059

Other trials in France

Hungary5 sites

  • "Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"

    Budapest, 1096

  • "Semmelweis Egyetem, Pulmonológiai Klinika"

    Budapest, 1125

  • Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen

    Debrecen, 4032

  • "Pécsi Tudományegyetem Klinikai Központ,

    Pécs, 7624

  • "Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"

    Szeged, 6720

Other trials in Hungary

India5 sites

  • Sanjivani Hospitals - Department of Cardiology

    Ahmedabad, 380015

  • Apollo Hospitals, Chennai

    Chennai, 600006

  • Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai

    Chennai, 600101

  • CARE Hospitals Nampally, Cardiology Dep. Hyderabad

    Hyderabad, 500001

  • Apollo Indraprastha Hospitals

    New Delhi, 110076

Other trials in India

Israel5 sites

  • Carmel Medical Center, Pulmonary Unit

    Haifa, 34362

  • Pulmonology Institute, Hadassah University Hospital at Ein Karem

    Jerusalem, 91120

  • Rabin Medical Centre - Pulmonology

    Petach Tikvah, 49100

  • Kaplan Medical - Pulmonary Institute

    Rehovot, 76100

  • The Chaim Sheba Med Ctr -Pulmonology

    Tel HaShomer, 52621

Other trials in Israel

South Korea5 sites

  • Gil Medical Centre

    Incheon, 405-760

  • Seoul Nathional University Hospital

    Seoul, 110-744

  • Yonsei University Health System Dept of Cardiology

    Seoul, 120-752

  • Samsung Medical Center, Division of Cardiology

    Seoul, 135-710

  • "The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"

    Seoul, 137-701

Other trials in South Korea

Netherlands4 sites

  • VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48

    Amsterdam, 1081 HV

  • Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases

    Maastricht, 6229 HX

  • St. Antonius Ziekenhuis afdeling Longziekten

    Nieuwegein, 3430 EM

  • Erasmus Medisch Centrum Rotterdam afdeling longziekten

    Rotterdam, 3015 GD

Other trials in Netherlands

Poland4 sites

  • "Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"

    Gdansk, 80-952

  • "Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"

    Krakow, 31-202

  • "Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"

    Lodz, 91-347

  • "Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"

    Warsaw, 01-138

Other trials in Poland

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset, Kardiologi

    Gothenburg, SE-413 45

  • Linköping University Hospital, Cardiology

    Linköping, 58185

  • Umeå University Hospital, Cardiology (Umeå)

    Umeå, 90185

  • Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F

    Uppsala, 751 85

Other trials in Sweden

Switzerland4 sites

  • University Hospital Basel Division of Pneumology

    Basel, 4031

  • Universitätsspital Bern, Clinic for Pneumology (Inselspital)

    Bern, 3010

  • HUG Hôpitaux Universitaires de Genève; Pneumology, PAH

    Geneva, 1211

  • Kantonsspital St. Gallen Klinik für Pneumologie

    Sankt Gallen, 9007

Other trials in Switzerland

Turkey (Türkiye)4 sites

  • Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

    Adana, 01330

  • Istanbul Üniversitesi Kardiyoloji Enstitisü

    Istanbul, 34096

  • Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali

    Istanbul, 34899

  • Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

    Izmir, 35210

Other trials in Turkey (Türkiye)

Ukraine4 sites

  • "Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""

    Dnipropetrovsk, 49060

  • Health Care Municipal Institution, City Clinical Hospital #13

    Kharkiv, 61124

  • Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"

    Kyiv, 03680

  • Lviv Regional Clinical Hospital

    Lviv, 79010

Other trials in Ukraine

Belarus3 sites

  • The Republican Scientific-Practical Center "Cardiology"

    Minsk, 220036

  • Minsk City Hospital No. 9

    Minsk, 220116

  • Minsk Regional Clinical Hospital of the Red Banner of Labour

    Minsk, 223040

Other trials in Belarus

Chile3 sites

  • Instituto Nacional del Torax Teaching Dept

    Santiago, 7500691

  • Clinica Tabancura- Cardiology Unit

    Santiago, 7650018

  • Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares

    Santiago, 8330074

Other trials in Chile

Italy3 sites

  • Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare

    Bologna, 40138

  • Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia

    Naples, 80131

  • ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia

    Palermo, 90127

Other trials in Italy

Spain3 sites

  • Hosp Vall D'Hebron - Barcelona - Pneumology

    Barcelona, 8035

  • Clinic-Barcelona

    Barcelona, 8036

  • Hospital 12 Octubre

    Madrid, 28041

Other trials in Spain

United Kingdom3 sites

  • Golden Jubilee - Pulm Vascular Unit

    Glasgow, G81 4HX

  • Royal Free & Ucms Rheumatology Unit

    London, NW3 2QG

  • Hammersmith

    London, W12 0HS

Other trials in United Kingdom

Austria2 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Medical University of Vienna and AKH Cardiology

    Vienna, A-1090

Other trials in Austria

Belgium2 sites

  • Ulb Erasme, Cardiology

    Brussels, 1070

  • University Hospital Gasthuisberg - Pneumologie

    Leuven, 3000

Other trials in Belgium

Colombia2 sites

  • Fundacion Cardio Infantil

    Bogotá

  • Fundacion Clinica Shaio

    Bogotá

Other trials in Colombia

Denmark2 sites

  • Aarhus University Hospital , Cardiology

    Aarhus, 8200

  • Rigshospitalet, Hjertemedicinsk klinik - Cardiology

    Copenhagen, 2100

Other trials in Denmark

Mexico2 sites

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian

    Mexico City, 14000

  • Instituto Nacional de Cardiologia (INC) Ignacio Chavez

    Mexico City, 14080

Other trials in Mexico

Peru2 sites

  • Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2

    Lima, 11

  • Instituto de Enfermedades Respiratorias Clinica San Gabriel

    Lima, 32

Other trials in Peru

Romania2 sites

  • "Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"

    Bucharest, 050159

  • "Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"

    Iași, 700115

Other trials in Romania

Serbia2 sites

  • "Klinički Centar Srbije, Klinika za pulmologiju"

    Belgrade, 11000

  • "Kliničko-bolnički centar Zemun, Kardiološko odeljenje"

    Belgrade, 11080

Other trials in Serbia

Taiwan2 sites

  • Kaohsiung Veterans General Hospital (KVGH)

    Kaohsiung City

  • National Taiwan University Hospital / Department of Surgery

    Taipei, 100

Other trials in Taiwan

Czechia1 site

  • Gen Faculty Hosp Prague Cardiology Clin

    Prague, 128 08

Other trials in Czechia

Greece1 site

  • Onasseio Cardiosurgical Hospital

    Athens, 176 74

Other trials in Greece

Ireland1 site

  • Mater Miscordiae University Hospital

    Dublin, Dublin 7

Other trials in Ireland

Malaysia1 site

  • Institut Jantung Negara (National Heart Institute)

    Kuala Lumpur, 50400

Other trials in Malaysia

Singapore1 site

  • National Heart Centre (NHC) Singapore

    Singapore, 168752

Other trials in Singapore

Slovakia1 site

  • Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.

    Bratislava, 833 48

Other trials in Slovakia

Thailand1 site

  • Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine

    Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: 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.

Being tested
Selexipag, Placebo
Keywords
pulmonary arterial hypertension, PAH
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelexipagDrug

    Also called ACT-293987

    Selexipag 200 µg tablets

  • PlaceboDrug

    Placebo tablets matching selexipag

Study groups in NCT01106014
Study groupRoleWhat they receive
1ExperimentalSelexipag is up-titrated from Day 1 to Week 12 to each patient's maximum tolerated dose in the range of 200-1600 µg twice a day (b.i.d.) in 200 µg steps starting with one 200 µg oral tablet on Day 1. From Day 2 onwards, a b.i.d. dose regimen with an interval of approximately 12 hours is followed. If this dose (selexipag 200 μg b.i.d.) is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg. Up-titration is followed by a stable maintenance treatment period from Week 12 onwards, up to Week 26, at the maximum tolerated dose
Receives: Drug: Selexipag
2Placebo comparatorMatching placebo is administered orally with a dosing interval of approximately12 h. A (mock) up-titration scheme is followed
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake

    Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points).

    Morbidity event was defined as any of the following events confirmed by the Critical Event committee:

    • Hospitalization for worsening of pulmonary arterial hypertension (PAH),
    • Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy,
    • Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH,
    • Disease progression which was defined by a decrease in 6-minute walk distance from baseline (>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline.

    Note: The number of patients at risk decreased over time but this cannot be captured below

    Measured: Up to 7 days after end of double-blind treatment (maximum: 4.3 years)

Secondary outcomes (2)

  1. Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough

    The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day.

    Measured: Week 26

  2. Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2010 (estimated)
  2. Study start1 Dec 2009
  3. Primary completion1 Apr 2014
  4. Study completion1 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106014
Sponsor's protocol ID
AC-065A302
Acronym
GRIPHON
Status last verified
Oct 2025
First submitted
2 Apr 2010
Last updated
27 Oct 2025
Data monitoring committee
Yes

Publications

  • Sitbon O, Channick R, Chin KM, Frey A, Gaine S, Galie N, Ghofrani HA, Hoeper MM, Lang IM, Preiss R, Rubin LJ, Di Scala L, Tapson V, Adzerikho I, Liu J, Moiseeva O, Zeng X, Simonneau G, McLaughlin VV; GRIPHON Investigators. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2015 Dec 24;373(26):2522-33. doi: 10.1056/NEJMoa1503184.

    PubMed 26699168

  • Benza RL, Chin KM, Gaine S, Galie N, Hoeper MM, Lang IM, McLaughlin VV, Sitbon O, Doad G, Yen J, Tang X, Tapson V. Changes in REVEAL Lite 2 risk status are associated with long-term outcomes in patients with pulmonary arterial hypertension: A post-hoc analysis of the GRIPHON study. J Heart Lung Transplant. 2024 Dec;43(12):1998-2007. doi: 10.1016/j.healun.2024.08.019. Epub 2024 Aug 31.

    PubMed 39222737

  • 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.

    PubMed 34727317

  • Gaine S, Sitbon O, Channick RN, Chin KM, Sauter R, Galie N, Hoeper MM, McLaughlin VV, Preiss R, Rubin LJ, Simonneau G, Tapson V, Ghofrani HA, Lang I. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study. Chest. 2021 Jul;160(1):277-286. doi: 10.1016/j.chest.2021.01.066. Epub 2021 Feb 3.

    PubMed 33545163

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 182 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Germany, Russia, Australia, Canada and 34 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake (time frame: Up to 7 days after end of double-blind treatment (maximum: 4.3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01106014, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.

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