Clinical Trial Finder

ACT-293987 in Pulmonary Arterial Hypertension

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01112306
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Aline Frey
Principal Investigator Affiliation Actelion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Korea, Republic of, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: 1

ACT-293987, twice daily

Interventions

Drug: - ACT-293987

Tablets, twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mobile, Alabama

Status

Address

Mobile, Alabama,

Phoenix, Arizona

Status

Address

Phoenix, Arizona,

Tucson, Arizona

Status

Address

Tucson, Arizona,

La Jolla, California

Status

Address

La Jolla, California,

Los Angeles, California

Status

Address

Los Angeles, California,

Sacramento, California

Status

Address

Sacramento, California,

Torrance, California

Status

Address

Torrance, California,

Newark, Delaware

Status

Address

Newark, Delaware,

Atlanta, Georgia

Status

Address

Atlanta, Georgia,

Augusta, Georgia

Status

Address

Augusta, Georgia,

Austell, Georgia

Status

Address

Austell, Georgia,

Carmel, Indiana

Status

Address

Carmel, Indiana,

Iowa City, Iowa

Status

Address

Iowa City, Iowa,

Kansas, Kansas

Status

Address

Kansas, Kansas,

Louisville, Kentucky

Status

Address

Louisville, Kentucky,

New Orleans, Louisiana

Status

Address

New Orleans, Louisiana,

Baltimore, Maryland

Status

Address

Baltimore, Maryland,

Boston, Massachusetts

Status

Address

Boston, Massachusetts,

Ann Arbor, Michigan

Status

Address

Ann Arbor, Michigan,

Detroit, Michigan

Status

Address

Detroit, Michigan,

Troy, Michigan

Status

Address

Troy, Michigan,

Rochester, Minnesota

Status

Address

Rochester, Minnesota,

Chesterfield, Missouri

Status

Address

Chesterfield, Missouri,

Saint Louis, Missouri

Status

Address

Saint Louis, Missouri,

Newark, New Jersey

Status

Address

Newark, New Jersey,

Bronx, New York

Status

Address

Bronx, New York,

Islandia, New York

Status

Address

Islandia, New York,

New York, New York

Status

Address

New York, New York,

Durham, North Carolina

Status

Address

Durham, North Carolina,

Winston-Salem, North Carolina

Status

Address

Winston-Salem, North Carolina,

Cincinnati, Ohio

Status

Address

Cincinnati, Ohio,

Cleveland, Ohio

Status

Address

Cleveland, Ohio,

Columbus, Ohio

Status

Address

Columbus, Ohio,

Bend, Oregon

Status

Address

Bend, Oregon,

Portland, Oregon

Status

Address

Portland, Oregon,

Doylestown, Pennsylvania

Status

Address

Doylestown, Pennsylvania,

Philadelphia, Pennsylvania

Status

Address

Philadelphia, Pennsylvania,

York, Pennsylvania

Status

Address

York, Pennsylvania,

Nashville, Tennessee

Status

Address

Nashville, Tennessee,

Dallas, Texas

Status

Address

Dallas, Texas,

Houston, Texas

Status

Address

Houston, Texas,

Norfolk, Virginia

Status

Address

Norfolk, Virginia,

Richmond, Virginia

Status

Address

Richmond, Virginia,

Madison, Wisconsin

Status

Address

Madison, Wisconsin,

Milwaukee, Wisconsin

Status

Address

Milwaukee, Wisconsin,

International Sites

Buenos Aires, Argentina

Status

Address

Buenos Aires, ,

Cordoba, Argentina

Status

Address

Cordoba, ,

Corrientes, Argentina

Status

Address

Corrientes, ,

Adelaide, Australia

Status

Address

Adelaide, ,

Bedford Park, Australia

Status

Address

Bedford Park, ,

Chermside, Australia

Status

Address

Chermside, ,

Concord, Australia

Status

Address

Concord, ,

Darlinghurst, Australia

Status

Address

Darlinghurst, ,

Fitzroy, Australia

Status

Address

Fitzroy, ,

Hobart, Australia

Status

Address

Hobart, ,

Murdoch, Australia

Status

Address

Murdoch, ,

New Lambton, Australia

Status

Address

New Lambton, ,

Parkville, Australia

Status

Address

Parkville, ,

Graz, Austria

Status

Address

Graz, ,

Vienna, Austria

Status

Address

Vienna, ,

Minsk, Belarus

Status

Address

Minsk, ,

Brussels, Belgium

Status

Address

Brussels, ,

Leuven, Belgium

Status

Address

Leuven, ,

Edmonton, Alberta, Canada

Status

Address

Edmonton, Alberta,

Vancouver, British Columbia, Canada

Status

Address

Vancouver, British Columbia,

Winnipeg, Manitoba, Canada

Status

Address

Winnipeg, Manitoba,

Ottawa, Ontario, Canada

Status

Address

Ottawa, Ontario,

Toronto, Ontario, Canada

Status

Address

Toronto, Ontario,

Montreal, Quebec, Canada

Status

Address

Montreal, Quebec,

Saskatoon, Saskatchewan, Canada

Status

Address

Saskatoon, Saskatchewan,

Quebec, Canada

Status

Address

Quebec, ,

Santiago De Chile, Chile

Status

Address

Santiago De Chile, ,

Beijing, China

Status

Address

Beijing, ,

Guangzhou, China

Status

Address

Guangzhou, ,

Shanghai, China

Status

Address

Shanghai, ,

Bogota, Colombia

Status

Address

Bogota, ,

Praha 2, Czechia

Status

Address

Praha 2, ,

Arhus, Denmark

Status

Address

Arhus, ,

Copenhagen, Denmark

Status

Address

Copenhagen, ,

Bron Cedex, France

Status

Address

Bron Cedex, ,

Le Kremlin-Bicetre Cedex, France

Status

Address

Le Kremlin-Bicetre Cedex, ,

Lille Cedex, France

Status

Address

Lille Cedex, ,

Toulouse Cedex 9, France

Status

Address

Toulouse Cedex 9, ,

Berlin, Germany

Status

Address

Berlin, ,

Dresden, Germany

Status

Address

Dresden, ,

Giessen, Germany

Status

Address

Giessen, ,

Greifswald, Germany

Status

Address

Greifswald, ,

Hannover, Germany

Status

Address

Hannover, ,

Heidelberg, Germany

Status

Address

Heidelberg, ,

Köln, Germany

Status

Address

Köln, ,

Leipzig, Germany

Status

Address

Leipzig, ,

Löwenstein, Germany

Status

Address

Löwenstein, ,

Regensburg, Germany

Status

Address

Regensburg, ,

Alexandroupoli, Greece

Status

Address

Alexandroupoli, ,

Athens, Greece

Status

Address

Athens, ,

Thessaloniki, Greece

Status

Address

Thessaloniki, ,

Budapest, Hungary

Status

Address

Budapest, ,

Debrecen, Hungary

Status

Address

Debrecen, ,

Pecs, Hungary

Status

Address

Pecs, ,

Szeged, Hungary

Status

Address

Szeged, ,

Ahmedabad, India

Status

Address

Ahmedabad, ,

Chennai, India

Status

Address

Chennai, ,

Hyderabad, India

Status

Address

Hyderabad, ,

Dublin, Ireland

Status

Address

Dublin, ,

Haifa, Israel

Status

Address

Haifa, ,

Jerusalem, Israel

Status

Address

Jerusalem, ,

Petah Tikva, Israel

Status

Address

Petah Tikva, ,

Rehovot, Israel

Status

Address

Rehovot, ,

Tel Aviv, Israel

Status

Address

Tel Aviv, ,

Tel-Hashomer, Israel

Status

Address

Tel-Hashomer, ,

Incheon, Korea, Republic of

Status

Address

Incheon, ,

Seoul, Korea, Republic of

Status

Address

Seoul, ,

Kuala Lumpur, Malaysia

Status

Address

Kuala Lumpur, ,

Ciudad de Mexico, Mexico

Status

Address

Ciudad de Mexico, ,

Amsterdam, Netherlands

Status

Address

Amsterdam, ,

Maastricht, Netherlands

Status

Address

Maastricht, ,

Rotterdam, Netherlands

Status

Address

Rotterdam, ,

Lima, Peru

Status

Address

Lima, ,

Gdansk, Poland

Status

Address

Gdansk, ,

Krakow, Poland

Status

Address

Krakow, ,

Otwock, Poland

Status

Address

Otwock, ,

Łódź, Poland

Status

Address

Łódź, ,

Bucuresti, Romania

Status

Address

Bucuresti, ,

Iasi, Romania

Status

Address

Iasi, ,

Barnaul, Russian Federation

Status

Address

Barnaul, ,

Ekaterinburg, Russian Federation

Status

Address

Ekaterinburg, ,

Kemerovo, Russian Federation

Status

Address

Kemerovo, ,

Moscow, Russian Federation

Status

Address

Moscow, ,

Novosibirsk, Russian Federation

Status

Address

Novosibirsk, ,

St Petersburg, Russian Federation

Status

Address

St Petersburg, ,

Tomsk, Russian Federation

Status

Address

Tomsk, ,

Belgrade, Serbia

Status

Address

Belgrade, ,

Singapore, Singapore

Status

Address

Singapore, ,

Bratislava, Slovakia

Status

Address

Bratislava, ,

Košice, Slovakia

Status

Address

Košice, ,

Barcelona, Spain

Status

Address

Barcelona, ,

Madrid, Spain

Status

Address

Madrid, ,

Goteborg, Sweden

Status

Address

Goteborg, ,

Linköping, Sweden

Status

Address

Linköping, ,

Umea, Sweden

Status

Address

Umea, ,

Uppsala, Sweden

Status

Address

Uppsala, ,

Basel, Switzerland

Status

Address

Basel, ,

Bern, Switzerland

Status

Address

Bern, ,

Genève 14, Switzerland

Status

Address

Genève 14, ,

Lausanne, Switzerland

Status

Address

Lausanne, ,

Kaohsiung, Taiwan

Status

Address

Kaohsiung, ,

Taipei, Taiwan

Status

Address

Taipei, ,

Khon Kaen, Thailand

Status

Address

Khon Kaen, ,

Adana, Turkey

Status

Address

Adana, ,

Istanbul, Turkey

Status

Address

Istanbul, ,

İzmir, Turkey

Status

Address

İzmir, ,

Dnipro, Ukraine

Status

Address

Dnipro, ,

Kharkiv, Ukraine

Status

Address

Kharkiv, ,

Kyiv, Ukraine

Status

Address

Kyiv, ,

Lviv, Ukraine

Status

Address

Lviv, ,

Glasgow, United Kingdom

Status

Address

Glasgow, ,

London, United Kingdom

Status

Address

London, ,

Powered By

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

Submit Feedback

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation in a clinical trial or study.