A randomised, double-blind,placebo-controlled, multi-centre, dose escalation study to evaluate the safety and the preliminary efficacy of recombinant factor VIIa (NovoSeven/Niastase) in subjects with brain contusions.
- Conditions
- Prevention of early haemorragic progression in brain contusionMedDRA version: 6.1Level: PTClassification code 10052346
- Registration Number
- EUCTR2004-000088-92-IT
- Lead Sponsor
- OVO NORDISK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method