CLINICAL TRIALS PROFILE FOR OPSUMIT

All Clinical Trials for OPSUMIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02050802 ↗	Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects	Completed	Actelion	Phase 1	2011-08-01	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.
NCT02126943 ↗	OPsumit USers Registry	Completed	Actelion		2014-04-30	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 setting.
NCT02476864 ↗	Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults	Completed	Actelion	Phase 1	2015-08-01	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.
NCT02651272 ↗	Macitentan in Pulmonary Hypertension of Sickle Cell Disease	Terminated	Actelion	Phase 2	2015-07-01	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.
NCT02651272 ↗	Macitentan in Pulmonary Hypertension of Sickle Cell Disease	Terminated	Boston University	Phase 2	2015-07-01	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.
NCT02885012 ↗	Crossover Study From Macitentan or Bosentan Over to Ambrisentan	Terminated	Ochsner Health System	Phase 4	2016-06-01	The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
NCT02885012 ↗	Crossover Study From Macitentan or Bosentan Over to Ambrisentan	Terminated	Medical University of South Carolina	Phase 4	2016-06-01	The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).

Clinical Trial Conditions for OPSUMIT

Condition Name

Condition Name for OPSUMIT
Intervention	Trials
Healthy	7
Pulmonary Arterial Hypertension	3
Healthy Subjects	2
Sickle Cell Disease	1

Condition MeSH

Condition MeSH for OPSUMIT
Intervention	Trials
Hypertension	5
Pulmonary Arterial Hypertension	3
Familial Primary Pulmonary Hypertension	3
Hypertension, Pulmonary	2

Clinical Trial Locations for OPSUMIT

Trials by Country

Trials by Country for OPSUMIT
Location	Trials
United States	65
Belgium	4
Germany	3
Japan	2
Canada	2

Trials by US State

Trials by US State for OPSUMIT
Location	Trials
California	4
Arizona	3
Massachusetts	3
Louisiana	2
Kentucky	2

Clinical Trial Progress for OPSUMIT

Clinical Trial Phase

Clinical Trial Phase for OPSUMIT
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for OPSUMIT
Clinical Trial Phase	Trials
Completed	6
Not yet recruiting	4
Recruiting	4

Clinical Trial Sponsors for OPSUMIT

Sponsor Name

Sponsor Name for OPSUMIT
Sponsor	Trials
Actelion	11
University of California, Los Angeles	2
Janssen Research & Development, LLC	2

Sponsor Type

Sponsor Type for OPSUMIT
Sponsor	Trials
Industry	15
Other	7