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Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00426803
First received: January 24, 2007
Last updated: June 26, 2012
Last verified: September 2011

January 24, 2007
June 26, 2012
August 2002
June 2004   (final data collection date for primary outcome measure)
Reducing haematoma growth [ Designated as safety issue: No ]
Reducing haematoma growth
Complete list of historical versions of study NCT00426803 on ClinicalTrials.gov Archive Site
Reducing disability and improving clinical outcome [ Designated as safety issue: No ]
Reducing disability and improving clinical outcome after 3 months
Not Provided
Not Provided
 
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Intracerebral Haemorrhage
Drug: activated recombinant human factor VII
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with secondary ICH
  • Pre-existing disability
  • Haemophilia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Croatia,   Denmark,   Finland,   Germany,   Italy,   Malaysia,   Netherlands,   New Zealand,   Norway,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
NCT00426803
F7ICH-1371
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Nicolai C. Brun, MD, Ph.D Novo Nordisk A/S
Novo Nordisk A/S
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP