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Last Updated: October 21, 2019

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CLINICAL TRIALS PROFILE FOR MACITENTAN

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Clinical Trials for Macitentan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00660179 Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension Completed Actelion Phase 3 2008-05-01 The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.
NCT00667823 Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension Active, not recruiting Actelion Phase 3 2008-10-01 The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
NCT00903331 Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study Completed Actelion Phase 2 2009-05-01 The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.
NCT01346930 Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis Withdrawn Actelion Phase 2 2011-07-01 The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).
NCT01474109 Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients Completed Actelion Phase 3 2011-12-01 The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. Other objectives include: - the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. - the evaluation of the safety and tolerability of macitentan in these patients. - the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.
NCT01474122 Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients Terminated Actelion Phase 3 2011-12-01 The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers (DU). Other objectives include: - the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. - the evaluation of the safety and tolerability of macitentan in these patients. - the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.
NCT01499251 Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma Terminated Actelion Phase 1 2012-01-01 This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide in adult patients with recurrent glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation Period with a traditional 3+3 design will determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide. A Phase 1b Period will expand the safety and tolerability data of two doses of macitentan and dose-dense temozolomide selected from the Dose Escalation Period and explore efficacy. An Ancillary Study will further evaluate the effects of macitentan on biomarkers in brain tumor tissue. The study is planned to have a minimum duration of 12 months. The study will end when all patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the study have completed a visit at month 12 and 30 days of safety follow-up.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Macitentan

Condition Name

Condition Name for Macitentan
Intervention Trials
Pulmonary Arterial Hypertension 15
Pulmonary Hypertension 4
Healthy Subjects 3
Chronic Thromboembolic Pulmonary Hypertension 2
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Condition MeSH

Condition MeSH for Macitentan
Intervention Trials
Hypertension 25
Familial Primary Pulmonary Hypertension 17
Hypertension, Pulmonary 7
Scleroderma, Systemic 3
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Clinical Trial Locations for Macitentan

Trials by Country

Trials by Country for Macitentan
Location Trials
United States 234
Canada 18
Germany 17
France 17
China 15
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Trials by US State

Trials by US State for Macitentan
Location Trials
Texas 15
Ohio 14
California 12
Massachusetts 11
Missouri 10
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Clinical Trial Progress for Macitentan

Clinical Trial Phase

Clinical Trial Phase for Macitentan
Clinical Trial Phase Trials
Phase 4 5
Phase 3 17
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Macitentan
Clinical Trial Phase Trials
Recruiting 10
Not yet recruiting 9
Completed 8
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Clinical Trial Sponsors for Macitentan

Sponsor Name

Sponsor Name for Macitentan
Sponsor Trials
Actelion 36
Medidata Solutions 2
Almac Clinical Technologies 2
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Sponsor Type

Sponsor Type for Macitentan
Sponsor Trials
Industry 41
Other 24
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