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Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00061022
First received: May 20, 2003
Last updated: November 10, 2010
Last verified: November 2010
History of Changes

May 20, 2003
November 10, 2010
May 2003
September 2006   (final data collection date for primary outcome measure)
Global disability on modified Rankin scale at 90 days.
Not Provided
Complete list of historical versions of study NCT00061022 on ClinicalTrials.gov Archive Site
  • NIH stroke scale
  • Barthel Index
  • Stroke Impact Scale
  • EQ-5D all at 90 days
  • Safety outcomes
Not Provided
Not Provided
Not Provided
 
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
SAINT (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

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cerebral Stroke
  • Stroke, Acute
  • Cerebrovascular Stroke
  • Ischemic Attack, Transient
Drug: NXY-059
Not Provided
Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3200
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females
  • Acute ischemic stroke with limb weakness
  • Onset of symptoms within 6 hours
  • Full functional independence prior to the present stroke

Exclusion Criteria:

  • Unconsciousness
  • Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
  • Severe illness with life expectancy less than 6 months.
  • Known severe kidney disorder.
  • Current known alcohol or illicit drug abuse or dependence.
  • Pregnant or breast-feeding.
  • Treatment with acetazolamide and methotrexate is not permitted during the infusion
  • Participation in a previous clinical study within 30 days.
  • Meets all other exclusion criteria.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Korea, Republic of,   Mexico,   New Zealand,   Philippines,   Poland,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Switzerland,   Taiwan,   United Kingdom
 
NCT00061022
SA-NXY-0007, 007, SAINT 2
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca NXY-059 Medical Science Director, MD AstraZeneca
AstraZeneca
November 2010

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