ACT-293987 in Pulmonary Arterial Hypertension

March 28, 2025 updated by: Actelion

Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

709

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
  • Australia
      • Adelaide, Australia
      • Bedford Park, Australia
      • Chermside, Australia
      • Concord, Australia
      • Darlinghurst, Australia
      • Fitzroy, Australia
      • Hobart, Australia
      • Murdoch, Australia
      • New Lambton, Australia
      • Parkville, Australia
  • Austria
      • Graz, Austria
      • Vienna, Austria
  • Belarus
      • Minsk, Belarus
  • Belgium
      • Brussels, Belgium
      • Leuven, Belgium
  • Canada
      • Quebec, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Chile
      • Santiago De Chile, Chile
  • China
      • Beijing, China
      • Guangzhou, China
      • Shanghai, China
  • Colombia
      • Bogota, Colombia
  • Czechia
      • Praha 2, Czechia
  • Denmark
      • Arhus, Denmark
      • Copenhagen, Denmark
  • France
      • Bron Cedex, France
      • Le Kremlin-Bicetre Cedex, France
      • Lille Cedex, France
      • Toulouse Cedex 9, France
  • Germany
      • Berlin, Germany
      • Dresden, Germany
      • Giessen, Germany
      • Greifswald, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Köln, Germany
      • Leipzig, Germany
      • Löwenstein, Germany
      • Regensburg, Germany
  • Greece
      • Alexandroupoli, Greece
      • Athens, Greece
      • Thessaloniki, Greece
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Pecs, Hungary
      • Szeged, Hungary
  • India
      • Ahmedabad, India
      • Chennai, India
      • Hyderabad, India
  • Ireland
      • Dublin, Ireland
  • Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Petah Tikva, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Tel-Hashomer, Israel
  • Korea, Republic of
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
  • Mexico
      • Ciudad de Mexico, Mexico
  • Netherlands
      • Amsterdam, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
  • Peru
      • Lima, Peru
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Otwock, Poland
  • Romania
      • Bucuresti, Romania
      • Iasi, Romania
  • Russian Federation
      • Barnaul, Russian Federation
      • Ekaterinburg, Russian Federation
      • Kemerovo, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • St Petersburg, Russian Federation
      • Tomsk, Russian Federation
  • Serbia
      • Belgrade, Serbia
  • Singapore
      • Singapore, Singapore
  • Slovakia
      • Bratislava, Slovakia
      • Košice, Slovakia
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
  • Sweden
      • Goteborg, Sweden
      • Linköping, Sweden
      • Umea, Sweden
      • Uppsala, Sweden
  • Switzerland
      • Basel, Switzerland
      • Bern, Switzerland
      • Genève 14, Switzerland
      • Lausanne, Switzerland
  • Taiwan
      • Kaohsiung, Taiwan
      • Taipei, Taiwan
  • Thailand
      • Khon Kaen, Thailand
  • Turkey
      • Adana, Turkey
      • Istanbul, Turkey
      • İzmir, Turkey
  • Ukraine
      • Dnipro, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
  • United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Sacramento, California, United States
      • Torrance, California, United States
    • Delaware
      • Newark, Delaware, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Austell, Georgia, United States
    • Indiana
      • Carmel, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • Saint Louis, Missouri, United States
    • New Jersey
      • Newark, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • Islandia, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Bend, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • York, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ACT-293987, twice daily
Drug: ACT-293987
Tablets, twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation
Time Frame: Up to 3 days after study drug discontinuation (Up to 10.5 years)
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
Time Frame: Up to 3 days after study drug discontinuation (Up to 10.5 years)
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
Time Frame: Up to 10.5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Alive Participants
Time Frame: Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates.
Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Aline Frey, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2010

Primary Completion (Actual)

August 26, 2021

Study Completion (Actual)

August 26, 2021

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimated)

April 28, 2010

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-065A303
  • 2009-014992-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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