NCT00940095

Clazosentan in Aneurysmal Subarachnoid Hemorrhage

A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following: 1. Death (all causes). 2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 4. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA). An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DRUG	Clazosentan 5 m/h	Continuous intravenous infusion of clazosentan (5 mg/h)
DRUG	Clazosentan 15 mg/h	Continuous intravenous infusion of clazosentan clazosentan (15 mg/h)
DRUG	Placebo	Continuous intravenous infusion of placebo-matching clazosentan

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-10-01
• Completion: 2011-01-01
• First posted: 2009-07-15
• Last updated: 2018-07-09

Locations

145 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan