A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. (UMBRELLA)
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|ClinicalTrials.gov Identifier: NCT03422328|
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2018
Last Update Posted : November 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension||Drug: macitentan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study is designed as an open-label, single-arm, multicenter trial in which all participants 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 study".|
|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|
|Actual Study Start Date :||April 5, 2018|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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 Event [ Time Frame: From Day 1 to End of study (EoS) visit (an average of 3 years) ]An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A treatment-emergent AE is any AE temporally associated with the use of study treatment.
- Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment [ Time Frame: From Day 1 to EoS visit (an average of 3 years) ]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 (an average of 3 years) ]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 EoS visit (an average of 3 years) ]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 (an average of 3 years) ]The proportion of patients who worsened, remain unchanged or improved from baseline to each scheduled time-point in WHO function will be calculated, 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 (an average of 3 years) ]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 estimated.
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:||Marek Sochor||Actelion|