Trials / Completed
CompletedNCT00144014
Safety and Efficacy Study in Acute Ischaemic Stroke
A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Vernalis (R&D) Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
Detailed description
An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | V10153 | Single acute intravenous bolus dose up to 10 mg/kg |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2008-11-01
- Completion
- 2009-03-01
- First posted
- 2005-09-02
- Last updated
- 2016-06-03
Locations
28 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00144014. Inclusion in this directory is not an endorsement.