Safety and Effectiveness of NXY-059 for the Treatment of Patients who have Suffered from a Stroke

Study identifier:SA-NXY-0006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

SAINT I (Stroke – Acute Ischemic – NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke.

Medical condition

Cerebral Stroke

Phase

Phase 3

Healthy volunteers

No

Study drug

NXY-059

Sex

All

Actual Enrollment

1700

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2003
Primary Completion Date: 01 Feb 2005
Study Completion Date: 01 Feb 2005

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria