Pulmonary arterial hypertension MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Concentration unit: mg milligram(s)
Concentration type
Sponsors
ACTELION Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent prior to any study-mandated procedure. • Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled. • Women of childbearing potential must: – have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC-055-310) and agree to perform monthly serum pregnancy tests. – agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Patients who prematurely discontinued study drug in the ORCHESTRA study (AC-055-310). • Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study. • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.;Secondary Objective: N/A;Primary end point(s): Safety endpoints • Treatment-emergent adverse events (AEs)1 • AEs leading to premature discontinuation of study drug • Treatment-emergent serious adverse events (SAEs) • Proportion of patients with treatment-emergent ALT and/or AST abnormality (> 3, > 5, and > 8 × ULN) associated or not with total bilirubin > 2 × ULN, up to EOT. • Proportion of patients with treatment-emergent hemoglobin abnormality (= 100 g/L, and = 80 g/L), up to EOT.;Timepoint(s) of evaluation of this end point: Monthly laboratory test and 6-Monthly visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Italy, Spain
Contacts
Public ContactGlobal Medical Information
ACTELION Pharmaceuticals Ltd.
Outcome results
None listed