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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00660179 |
The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of ACT-064992 (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that ACT-064992 prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of ACT-064992 in the treatment of patients with symptomatic PAH.
Condition | Intervention | Phase |
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Pulmonary Arterial Hypertension |
Drug: ACT-064992 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Event-Driven, Phase III Study to Assess the Effects of ACT-064992 on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension |
Estimated Enrollment: | 525 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ACT-064992 tablet, 3 mg, once daily
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Drug: ACT-064992
Tablet, 3 mg dosage, once daily
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2: Experimental
ACT-064992 tablet, 10 mg, once daily
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Drug: ACT-064992
Tablet, 10 mg dosage, once daily
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3: Placebo Comparator
Matching ACT-064992 placebo, once daily
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Drug: Placebo
Matching ACT-064992 placebo, once daily
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with the following types of PAH belonging to groups 1.1 to 1.3 of the Venice classification:
Related to:
PAH diagnosis confirmed by hemodynamic evaluation performed prior to randomization and showing all of the following:
Exclusion Criteria:
Study Chair: | Loic Perchenet, PhD | Actelion |
Responsible Party: | Actelion ( Sebastien Roux, MD ) |
Study ID Numbers: | AC-055-302 |
Study First Received: | April 14, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00660179 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Ministry for Health and Women; Belarus: Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; China: State Food and Drug Administration; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Israel: Ministry of Health; Italy: The Italian Medicines Agency; Mexico: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Taiwan: Department of Health; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
pulmonary arterial hypertension SERAPHIN |
Idiopathic pulmonary hypertension Respiratory Tract Diseases Hypertension, Pulmonary |
Lung Diseases Vascular Diseases Hypertension |
Cardiovascular Diseases |