CLINICAL TRIALS PROFILE FOR MACITENTAN

All 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	Completed	Actelion	Phase 3	2008-10-17	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NCT01346930 ↗	Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis	Withdrawn	Actelion	Phase 2	2011-07-01	The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind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 continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients are 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.

Clinical Trial Conditions for Macitentan

Condition Name

Condition Name for Macitentan
Intervention	Trials
Pulmonary Arterial Hypertension	17
Healthy	9
Healthy Subjects	4
Pulmonary Hypertension	4

Condition MeSH

Condition MeSH for Macitentan
Intervention	Trials
Hypertension	31
Pulmonary Arterial Hypertension	20
Familial Primary Pulmonary Hypertension	19
Hypertension, Pulmonary	12

Clinical Trial Locations for Macitentan

Trials by Country

Trials by Country for Macitentan
Location	Trials
United States	369
Canada	31
France	26
Germany	25
China	21

Trials by US State

Trials by US State for Macitentan
Location	Trials
Texas	22
Ohio	20
California	19
Massachusetts	17
Arizona	16

Clinical Trial Progress for Macitentan

Clinical Trial Phase

Clinical Trial Phase for Macitentan
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	22
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Macitentan
Clinical Trial Phase	Trials
Completed	26
Recruiting	10
Terminated	10

Clinical Trial Sponsors for Macitentan

Sponsor Name

Sponsor Name for Macitentan
Sponsor	Trials
Actelion	47
Almac Clinical Technologies	2
Janssen, LP	2

Sponsor Type

Sponsor Type for Macitentan
Sponsor	Trials
Industry	59
Other	30