Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH) (CONSCIOUS-1)

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00111085
First received: May 17, 2005
Last updated: February 11, 2010
Last verified: February 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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:


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.

Enrollment: 413
Study Start Date: January 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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. Zuccarello
Cincinnati, Ohio, United States
Dr. Woo
Cleveland, 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, Alberta
Dr. Wong
Calgary, Alberta, Canada
Dr. Findlay
Edmonton, 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
Canada
Dr. Fleetwood
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Actelion
  More Information

No publications provided by Actelion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00111085     History of Changes
Other Study ID Numbers: AC-054-201
Study First Received: May 17, 2005
Last Updated: February 11, 2010
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:
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014