Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects
The study is intended to demonstrate that macitentan does not have an effect on cardiac
repolarization exceeding the threshold of regulatory concern after repeated administration of
daily oral doses of 10 and 30 mg to healthy male and female subjects.
Prospective observational drug registry developed to characterize the safety profile
(including primarily potential serious hepatic risks) and to describe clinical
characteristics and outcomes of patients newly treated with Opsumit in the post-marketing
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
A study conducted in healthy adults to investigate if a new macitentan tablet leads to the
same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as
the marketed macitentan tablet.
Macitentan in Pulmonary Hypertension of Sickle Cell Disease
This is a pilot study to assess the safety and efficacy of macitentan in patients with
pulmonary hypertension of sickle cell disease. This study will enroll approximately 10
subjects. Study participation for each subject will last approximately 24 weeks from
screening to end of treatment follow-up.
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