Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 12, 2004

Last Updated Date

March 18, 2009

Start Date ^†

July 2004

Current Primary Outcome Measures ^†

Global disability on modified Rankin scale at 90 days

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00075959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

NIH stroke scale
Barthel Index
Stroke Impact Scale

Original Secondary Outcome Measures ^†

NIH stroke scale
Barthel Index
Stroke Impact Scale

Descriptive Information

Brief Title ^†

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

Official Title ^†

CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH)

Brief Summary

This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^†

Intracerebral Hemorrhage

Intervention ^†

Drug: NXY-059

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

600

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Males and females
Intracerebral Hemorrhage as the cause of stroke symptoms
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 7 days.
Meets all other exclusion criteria

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00075959

Responsible Party

Secondary IDs ^††

0012, CHANT

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

AstraZeneca NXY-059 Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.