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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
This study has been completed.
First Received: January 24, 2007   Last Updated: October 14, 2009   History of Changes
Sponsor: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00426803
  Purpose

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.


Condition Intervention Phase
Intracerebral Haemorrhage
 Drug: activated recombinant human factor VII
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Parallel Groups, Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (NovoSeven®) in Acute Intracerebral Haemorrhage

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Reducing haematoma growth [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reducing disability and improving clinical outcome [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: August 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spontaneous intracranial haemorrhage (ICH) within 3 hours after first symptom

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426803

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92103-8466
Novo Nordisk Clinical Trial Call Center
Palo Alto, California, United States, 94304
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96813
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02114
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 11040
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10032
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Durham, North Carolina, United States, 27705
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45267-0525
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97201
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23226
Australia
Parkville, Australia, 3050
Austria
Graz, Austria, 8036
Belgium
Antwerpen, Belgium, 2020
Canada
Saint John, Canada, E2L 4L2
Toronto, Canada, M5G-2C4
Saskatoon, Canada, S7N 0W8
Mississauga, Canada, L5B 1B8
Vancouver, Canada, V5Z 3J5
Calgary, Canada, T2N 2T9
Croatia
Zagreb, Croatia, 10 000
Denmark
Aarhus, Denmark, 8000 C
Finland
Helsinki, Finland
Germany
Heidelberg, Germany, 69115
Italy
Perugia, Italy, 06126
Malaysia
Kuala Lumpur, Malaysia, 56000
Netherlands
Amsterdam, Netherlands, 1105 AZ
New Zealand
Otahuhu, Auckland, New Zealand
Norway
Bergen, Norway, 5021
Singapore
Singapore, Singapore, 308443
Spain
Girona, Spain, 17007
Sweden
Stockholm, Sweden, 118 83
Switzerland
Lausanne, Switzerland, 1011
Taiwan
Geuishang Shiang, Taiwan, 333
United Kingdom
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Nicolai C. Brun, MD, Ph.D Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers: F7ICH-1371
Study First Received: January 24, 2007
Last Updated: October 14, 2009
ClinicalTrials.gov Identifier: NCT00426803     History of Changes
Health Authority: Taiwan: Department of Health;   Spain: Spanish Agency of Medicines;   Singapore: Health Sciences Authority;   United Kingdom: Medicines Control Agency;   Croatia: Ministry of Health and Social Care;   Denmark: Danish Medicines Agency;   Canada: Health Canada;   Finland: Finnish Medicines Agency;   Netherlands: Dutch Health Care Inspectorate;   New Zealand: Food Safety Authority;   Austria: Federal Ministry for Health and Women;   Germany: Paul-Ehrlich-Institut;   Italy: National Monitoring Centre for Clinical Trials - Ministry of Health;   Switzerland: Swissmedic;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Norway: Norwegian Medicines Agency;   Sweden: Medical Products Agency;   United States: Food and Drug Administration;   Malaysia: Ministry of Health

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
 Cardiovascular Diseases
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 27, 2009



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