Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
NCT00660179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 742
Last updated 2015-09-28
Summary
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.
Conditions
Interventions
- DRUG
-
macitentan (ACT-064992)
Tablet, 3 mg dosage, once daily
- DRUG
-
macitentan (ACT-064992)
Tablet, 10 mg dosage, once daily
- DRUG
-
Matching placebo, once daily
Sponsors & Collaborators
-
Actelion
lead INDUSTRY
Principal Investigators
-
Loic Perchenet, PhD · Actelion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-04-30
Countries
- United States
- Argentina
- Australia
- Austria
- Belarus
- Belgium
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Croatia
- France
- Germany
- Hong Kong
- Hungary
- India
- Israel
- Italy
- Malaysia
- Mexico
- Netherlands
- Norway
- Peru
- Poland
- Romania
- Russia
- Serbia
- Singapore
- Slovakia
- South Africa
- Spain
- Sweden
- Taiwan
- Thailand
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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