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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
709

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
ACT-293987, twice daily
Drug: ACT-293987
Tablets, twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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