Recombinant Factor VIIa in Acute Intracerebral Haemorrhage - Tabular View

Tracking Information

First Received Date ^ICMJE

January 24, 2007

Last Updated Date

October 14, 2009

Start Date ^ICMJE

August 2002

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reducing haematoma growth [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Reducing haematoma growth

Change History

Complete list of historical versions of study NCT00426803 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reducing disability and improving clinical outcome [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Reducing disability and improving clinical outcome after 3 months

Descriptive Information

Brief Title ^ICMJE

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Intracerebral Haemorrhage

Intervention ^ICMJE

Drug: activated recombinant human factor VII

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

June 2004

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Patients with secondary ICH
Pre-existing disability
Haemophilia

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, Germany, Italy, Malaysia, Netherlands, New Zealand, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00426803

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

F7ICH-1371

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Nicolai C. Brun, MD, Ph.D

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

October 2009

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