Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00119626|
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : November 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Stroke Ischemic Attack, Transient||Drug: NXY-059||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1700 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||February 2005|
- Global disability on modified Rankin scale at 90 days.
- NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119626
|Glasgow, United Kingdom|
|Study Director:||AstraZeneca NXY-059 Medical Science Director, MD||AstraZeneca|