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Daiichi Sankyo
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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR OPSUMIT

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Clinical Trials for Opsumit

Trial ID Title Status Sponsor Phase Summary
NCT02050802 Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects Completed Actelion Phase 1 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 Recruiting Actelion N/A 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 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 Recruiting Actelion Phase 1 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 Recruiting Boston University Phase 1 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 Recruiting Ochsner Health System Phase 4 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).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Opsumit

Condition Name

Condition Name for Opsumit
Intervention Trials
Pulmonary Arterial Hypertension 2
Healthy Subjects 2
Healthy 1
Sickle Cell Disease 1
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Condition MeSH

Condition MeSH for Opsumit
Intervention Trials
Hypertension 3
Familial Primary Pulmonary Hypertension 2
Hypertension, Pulmonary 1
Anemia, Sickle Cell 1
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Clinical Trial Locations for Opsumit

Trials by Country

Trials by Country for Opsumit
Location Trials
United States 43
Germany 2
Czech Republic 1
Puerto Rico 1
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Trials by US State

Trials by US State for Opsumit
Location Trials
California 2
Louisiana 2
South Carolina 2
Massachusetts 2
Missouri 1
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Clinical Trial Progress for Opsumit

Clinical Trial Phase

Clinical Trial Phase for Opsumit
Clinical Trial Phase Trials
Phase 4 2
Phase 1 4
N/A 1
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Clinical Trial Status

Clinical Trial Status for Opsumit
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Not yet recruiting 2
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Clinical Trial Sponsors for Opsumit

Sponsor Name

Sponsor Name for Opsumit
Sponsor Trials
Actelion 5
Boston University 1
University of California, Los Angeles 1
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Sponsor Type

Sponsor Type for Opsumit
Sponsor Trials
Industry 5
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Fuji
Mallinckrodt
US Army
Moodys
Baxter
Teva
McKesson

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