The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (\>=) 2 year to less than (\<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.
Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of \>=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight \< 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.
Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.
The Republican Scientific-Practical Center ''Cardiology''
Minsk, Belarus
RECRUITINGMinsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk, Belarus
RECRUITINGUZ Leuven
Leuven, Belgium
COMPLETEDUniversity Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, Bulgaria
Frequency of Treatment Emergent Adverse Events (TEAEs)
An adverse event (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 intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Time frame: Baseline until End of Study (EOS) (up to 84 months)
Frequency of TEAEs Leading to Discontinuation
Frequency of TEAEs leading to discontinuation of study intervention will be reported. 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 intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Time frame: Baseline until EOS (up to 84 months)
Frequency of Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Baseline until EOS (up to 84 months)
Frequency of Deaths
Frequency of deaths will be reported.
Time frame: Baseline until EOS (up to 84 months)
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Beijing Anzhen Hospital
Beijing, China
RECRUITINGThe Second Xiangya Hospital of Central South Hospital
Changsha, China
RECRUITINGJiangsu Province Hospital
Nanjing, China
RECRUITINGQingdao Women and Children's Hospital
Qingdao, China
RECRUITINGChildrens Hospital of Shanghai
Shanghai, China
RECRUITINGThe First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
RECRUITING...and 33 more locations