Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
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|ClinicalTrials.gov Identifier: NCT02112487|
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : September 20, 2019
Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Macitentan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™|
|Actual Study Start Date :||June 23, 2014|
|Actual Primary Completion Date :||September 19, 2018|
|Actual Study Completion Date :||September 19, 2018|
10 mg once daily
10 mg once daily
Other Name: ACT-064992
- To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study. [ Time Frame: Baseline to end of treatment visit (around 6 months on average) ]
- Treatment-emergent adverse events (AEs)
- 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 x ULN) associated or not with total bilirubin > 2 x ULN.
- Proportion of patients with treatment-emergent hemoglobin abnormality (≦ 100 g/L, and ≦ 80 g/L)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112487
|Study Director:||Loïc Perchenet||Actelion|