A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Arterial Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.
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|ClinicalTrials.gov Identifier: NCT03422328|
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2018
Last Update Posted : December 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: macitentan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study is designed as an open-label, single-arm, multicenter trial in which all subjects roll over from a "parent study" in order to continue their dose of macitentan 10 mg once every day as already received in the "parent studies".|
|Masking:||None (Open Label)|
|Official Title:||mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies (UMBRELLA)|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||April 3, 2021|
|Estimated Study Completion Date :||May 2, 2021|
Experimental: Open-label macitentan 10 mg
10 mg macitentan film coated tablet, administered orally once daily
macitentan 10 mg, film-coated tablet, oral use
- Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment [ Time Frame: From Day 1 to End-of-Study (EoS) visit (36 months + 30 days follow-up) ]Any AE will be recorded that 1) is (temporally) associated with the use of study treatment whether or not considered by the investigator as related to study treatment and 2) leads to premature discontinuation of study medication.
- Incident rate of treatment-emergent serious adverse events (SAEs) [ Time Frame: From Day 1 to EoS visit (36 months + 30 days follow-up) ]Any SAE as defined by the ICH guidelines will be recorded. Any hepatic AE that leads to discontinuation of study treatment will be defined as SAE.
- Number of pregnancies with maternal exposure to macitentan [ Time Frame: From Day 1 to End-of-Treatment (EoT) visit (36 months) ]Pregnancies with maternal exposure to macitentan will be recorded.
- Change of WHO functional class to each scheduled time point [ Time Frame: From Day 1 to EoT visit (36 months) ]The proportion of patients who worsened, remain unchanged or improved from baseline to each scheduled time-point in WHO function will be collected, where baseline is the initial baseline from the "parent study" (or the double-blind core study preceding the "parent study").
- Assessment of survival status at End-of-Study (EoS) [ Time Frame: From Day 1 to EoS visit (36 months + 30 days follow-up) ]Time to death of all causes up to EoS from the date of randomization or enrollment in the "parent study" (or the double-blind core study preceding the "parent study") will be recorded.
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): NCT03422328
|Study Director:||Thomas Pfister, PhD||Actelion|