Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)

This study has been completed.

First Received: May 17, 2005 Last Updated: April 13, 2007 History of Changes

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00111085

Purpose

The purpose of the study is to measure how effective and safe three different doses of the drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.

Condition	Intervention	Phase
Vasospasm Following Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage Intracranial Vasospasm	Drug: clazosentan	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIb, Multi-Center, International, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Finding Study for the Prevention of Cerebral Vasospasm After aSAH by Intravenous Administration of Clazosentan, a Selective ETA Receptor Antagonist

Resource links provided by NLM:

Drug Information available for: Clazosentan

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

To assess the efficacy of 3 dose levels (1 mg/h, 5 mg/h and 15 mg/h) of clazosentan in preventing the occurrence of cerebral vasospasm following aSAH.

Secondary Outcome Measures:

To assess the ability of clazosentan to reduce the occurrence of early morbidity/mortality.
To assess the effect of clazosentan on clinical outcome.
To assess the safety and tolerability of three dose levels of clazosentan.

Estimated Enrollment:	400
Study Start Date:	December 2004
Estimated Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female patients aged 18 to 70 years (inclusive) or male patients aged 45 to 70 (inclusive) or males aged 18 to 44 (inclusive) who are surgically or naturally sterile or can personally sign the core Informed Consent
Patients with a ruptured saccular aneurysm that has been confirmed by digital subtraction angiography (DSA) and for which clipping or coiling (endovascular obliteration) is possible.
Patients with a diffuse or localized thick subarachnoid clot on baseline CT scan.
Start of screening within 48 hours post onset of aSAH clinical symptoms.
WFNS Grades I–IV, and those Grade V patients who improve to Grade IV or less after ventriculostomy.

Exclusion Criteria:

Patients with SAH due to other causes (e.g., trauma or rupture of fusiform or mycotic aneurysms)
Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood.
No visualized clot or presence of only localized thin clot on CT
Presence of any degree of cerebral vasospasm on screening angiogram

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111085

Locations

United States, Illinois
Dr. Giuseppe Lanzino
Peoria, Illinois, United States
United States, Indiana
Dr. Horner
Indianapolis, Indiana, United States
United States, Maryland
Dr. Aldrich
Baltimore, Maryland, United States
United States, Massachusetts
Dr. Ogilvy
Boston, Massachusetts, United States
United States, Ohio
Dr. Woo
Cleveland, Ohio, United States
Dr. Zuccarello
Cincinnati, Ohio, United States
United States, Pennsylvania
Dr. Zager
Philadelphia, Pennsylvania, United States
Dr. Rosenwasser
Philadelphia, Pennsylvania, United States
United States, Texas
Dr. George A. Lopez
Houston, Texas, United States
United States, Virginia
Dr. Bullock
Richmond, Virginia, United States
Canada
Dr. Fleetwood
Halifax, Nova Scotia, Canada
Canada, Alberta
Dr. Findlay
Edmonton, Alberta, Canada
Dr. Wong
Calgary, Alberta, Canada
Canada, British Columbia
Dr. Redekop
Vancouver, British Columbia, Canada
Canada, Ontario
Dr. Ferguson
Toronto, Ontario, Canada
Canada, Quebec
Dr. Bojanowski
Montreal, Quebec, Canada

Sponsors and Collaborators

Actelion

More Information

No publications provided

Study ID Numbers:	CONSCIOUS-1/ AC-054-201
Study First Received:	May 17, 2005
Last Updated:	April 13, 2007
ClinicalTrials.gov Identifier:	NCT00111085 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

aneurysmal subarachnoid hemorrhage (aSAH)
vasospasm
delayed ischemic neurological deficits (DIND)
computer tomography scan (CT scan)

digital subtraction angiography (DSA)
endothelin A receptor
clazosentan

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Vascular Diseases
Subarachnoid Hemorrhage
Central Nervous System Diseases
Cardiovascular Diseases

Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Vasospasm, Intracranial

ClinicalTrials.gov processed this record on February 08, 2010