symptomatic pulmonary arterial hypertension MedDRA version: 17.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 morbidity event and for whom a written approval to roll over into this study has been obtained from the Sponsor. • Men or women = 12 years of age: Only sites that have adequate pediatric pulmonary experience are allowed to enroll patients between 12 and 17 year of age. • Women of childbearing potential* with a negative pre-treatment serum pregnancy test and who consistently and correctly use (from screening and up to 28 days after study treatment discontinuation) a reliable method of contraception with a Pearl index of 50 years and not treated with any kind of HRT for at least 2 years prior to screening with amenorrhea for at least 24 consecutive months prior to screening and a serum FSH level of > 40 IU/L at screening. Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 513 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 79
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension (PAH).;Secondary Objective: N/A;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Medical Information
Actelion Pharmaceuticals Ltd
Outcome results
None listed