Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

Completed · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

Key facts

Study ID

NCT00667823

Run by

Actelion

People needed

550

Starts

2008-10-17

Expected to finish

2020-12-07

Last updated by the study team

2025-03-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to initiation of any study-mandated procedure.
• Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
• Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

You may not qualify if…

• Any major violation of protocol AC 055 302/SERAPHIN.
• Pregnancy or breast-feeding.
• AST and/or ALT > 3 times the upper limit of the normal range.
• 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.
• Known hypersensitivity to ACT 064992 or any of the excipients.

Where it is running

• Arizona Pulmonary Specialists — Phoenix, Arizona, United States
• University of California, San Diego — La Jolla, California, United States
• GLVA Healthcare Center — Los Angeles, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Liu Center for Pulmonary Hypertension — Torrance, California, United States
• University of Colorado CARDIAC AND VASCULAR CENTER — Aurora, Colorado, United States
• University of Florida - Division of Pulmonology — Gainesville, Florida, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease — Atlanta, Georgia, United States
• Pulmonary & Critical Care of Atlanta — Atlanta, Georgia, United States
• Atlanta Institute for Medical Research — Decatur, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa, Pulmonary Hypertension Program — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kentuckiana Pulmonary Associate, PLLC — Louisville, Kentucky, United States
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland School of Medicine; Division of Cardiology — Baltimore, Maryland, United States
• Pulmonary/Critical Care Division/Tufts New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Harper Univ. Hospital/ Wayne State University — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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