ACT-293987 in Pulmonary Arterial Hypertension

NCT01112306 | Completed Phase 3 Results DMC

• 2 other identifiers: AC-065A3032009-014992-31
• Study Type: interventional
• Target: 709
• Locations: 35 countries
• Sites: 150

Brief Summary

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)

Conditions

Pulmonary Arterial Hypertension

Keywords

Open-label; PAH; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation

  An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.

  Up to 3 days after study drug discontinuation (Up to 10.5 years)

• Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.

  Up to 3 days after study drug discontinuation (Up to 10.5 years)

• Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention

  An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.

  Up to 10.5 years

Secondary Outcomes (1)

• Percentage of Alive Participants

  Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Study Arms (1)

1

EXPERIMENTAL

ACT-293987, twice daily

Drug: ACT-293987

Interventions

ACT-293987 DRUG

Tablets, twice daily

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Study Sites (157)

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Newark, Delaware, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Austell, Georgia, United States

Location

Unknown Facility

Carmel, Indiana, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Troy, Michigan, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Chesterfield, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Newark, New Jersey, United States

Location

Unknown Facility

Islandia, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Bend, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Doylestown, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

York, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Corrientes, Argentina

Location

Unknown Facility

Córdoba, Argentina

Location

Unknown Facility

Adelaide, Australia

Location

Unknown Facility

Bedford Park, Australia

Location

Unknown Facility

Chermside, Australia

Location

Unknown Facility

Concord, Australia

Location

Unknown Facility

Darlinghurst, Australia

Location

Unknown Facility

Fitzroy, Australia

Location

Unknown Facility

Hobart, Australia

Location

Unknown Facility

Murdoch, Australia

Location

Unknown Facility

New Lambton, Australia

Location

Unknown Facility

Parkville, Australia

Location

Unknown Facility

Graz, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Minsk, Belarus

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, Canada

Location

Unknown Facility

Santiago, Chile

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Aarhus, Denmark

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Bron, France

Location

Unknown Facility

Le Kremlin-Bicêtre, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Giessen, Germany

Location

Unknown Facility

Greifswald, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Leipzig, Germany

Location

Unknown Facility

Löwenstein, Germany

Location

Unknown Facility

Regensburg, Germany

Location

Unknown Facility

Alexandroupoli, Greece

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Thessaloniki, Greece

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Debrecen, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Ahmedabad, India

Location

Unknown Facility

Chennai, India

Location

Unknown Facility

Hyderabad, India

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Haifa, Israel

Location

Unknown Facility

Jerusalem, Israel

Location

Unknown Facility

Petah Tikva, Israel

Location

Unknown Facility

Rehovot, Israel

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Tel Litwinsky, Israel

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Maastricht, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Lima, Peru

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Otwock, Poland

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Barnaul, Russia

Location

Unknown Facility

Kemerovo, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Novosibirsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Tomsk, Russia

Location

Unknown Facility

Yekaterinburg, Russia

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Bratislava, Slovakia

Location

Unknown Facility

Košice, Slovakia

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Linköping, Sweden

Location

Unknown Facility

Umeå, Sweden

Location

Unknown Facility

Uppsala, Sweden

Location

Unknown Facility

Basel, Switzerland

Location

Unknown Facility

Bern, Switzerland

Location

Unknown Facility

Geneva, Switzerland

Location

Unknown Facility

Lausanne, Switzerland

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Khon Kaen, Thailand

Location

Unknown Facility

Adana, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, Turkey (Türkiye)

Location

Unknown Facility

Izmir, Turkey (Türkiye)

Location

Unknown Facility

Dnipro, Ukraine

Location

Unknown Facility

Kharkiv, Ukraine

Location

Unknown Facility

Kyiv, Ukraine

Location

Unknown Facility

Lviv, Ukraine

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34727317 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

selexipag

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study had an open-label, uncontrolled design. Additional pulmonary arterial hypertension (PAH)-specific treatments were introduced in a limited percentage of participants and during a limited period of time. The study had a variable study duration across countries/territories depending on the availability of commercial selexipag. Limited safety data reporting was done in participants in China due to the human genetic resources (HGR) regulation finding after 20-December-2019.

Results Point of Contact

• Title: Scientific Leader
• Organization: Actelion Pharmaceuticals Ltd

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Aline Frey

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 28, 2010
• Study Start: July 7, 2010
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: March 30, 2025
• Results First Posted: September 19, 2022

Record last verified: 2025-03

Locations

US (45); TH (1); UA (4); AU (10); CL (1); IE (1); TU (3); BE (2); MY (1); GR (3); IL (6); NL (3); SG (1); RO (2); DE (10); CZ (1); PE (1); SE (1); AR (3); CO (1); KR (2); CN (3); SL (2); ES (2); RU (7); FR (4); IN (3); GB (2); DK (2); ME (1); TW (2); PL (4); CH (4); HU (4); CA (8)