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

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Mobile, Alabama,

Phoenix, Arizona

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Phoenix, Arizona,

Tucson, Arizona

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Tucson, Arizona,

La Jolla, California

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Los Angeles, California

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Sacramento, California

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Torrance, California

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Newark, Delaware

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Newark, Delaware,

Atlanta, Georgia

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Augusta, Georgia

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Austell, Georgia

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Carmel, Indiana

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Iowa City, Iowa

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Iowa City, Iowa,

Kansas, Kansas

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Louisville, Kentucky

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New Orleans, Louisiana

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Baltimore, Maryland

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Boston, Massachusetts

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Ann Arbor, Michigan

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Detroit, Michigan

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Troy, Michigan

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Troy, Michigan,

Rochester, Minnesota

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Rochester, Minnesota,

Chesterfield, Missouri

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Saint Louis, Missouri

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Newark, New Jersey

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Bronx, New York

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Islandia, New York

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New York, New York

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New York, New York,

Durham, North Carolina

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Durham, North Carolina,

Winston-Salem, North Carolina

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Winston-Salem, North Carolina,

Cincinnati, Ohio

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Cleveland, Ohio

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Cleveland, Ohio,

Columbus, Ohio

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Columbus, Ohio,

Bend, Oregon

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Bend, Oregon,

Portland, Oregon

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Doylestown, Pennsylvania

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Doylestown, Pennsylvania,

Philadelphia, Pennsylvania

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York, Pennsylvania

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Nashville, Tennessee

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Dallas, Texas

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Houston, Texas

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Norfolk, Virginia

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Norfolk, Virginia,

Richmond, Virginia

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Richmond, Virginia,

Madison, Wisconsin

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Madison, Wisconsin,

Milwaukee, Wisconsin

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Milwaukee, Wisconsin,

International Sites

Buenos Aires, Argentina

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Corrientes, Argentina

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Concord, Australia

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario,

Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Beijing, China

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Praha 2, Czechia

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Bron Cedex, France

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Le Kremlin-Bicêtre Cedex, France

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Toulouse Cedex 9, France

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Berlin, Germany

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Löwenstein, Germany

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Budapest, Hungary

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Szeged, Hungary

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Ahmedabad, India

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Chennai, India

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Dublin, Ireland

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Haifa, Israel

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Jerusalem, Israel

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Incheon, Korea, Republic of

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Kuala Lumpur, Malaysia

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Ciudad de Mexico, Mexico

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Amsterdam, Netherlands

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Lima, Peru

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Barnaul, Russian Federation

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Kemerovo, Russian Federation

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St Petersburg, Russian Federation

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Tomsk, Russian Federation

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Linköping, Sweden

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Umea, Sweden

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Uppsala, Sweden

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Basel, Switzerland

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Bern, Switzerland

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Kaohsiung, Taiwan

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Taipei, Taiwan

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Khon Kaen, Thailand

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Adana, Turkey

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Dnipro, Ukraine

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Glasgow, United Kingdom

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London, United Kingdom

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

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