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.
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.
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.
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Withdrawn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).
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
