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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00075959

Collaborator

(none)

600

Enrollment

Locations

Duration (Months)

9.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Drug: NXY-059	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

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)

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Global disability on modified Rankin scale at 90 days []

Secondary Outcome Measures

NIH stroke scale []
Barthel Index []
Stroke Impact Scale []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Scottsdale	Arizona	United States
3	Research Site	Fort Smith	Arkansas	United States
4	Research Site	Carmichael	California	United States
5	Research Site	Sacramento	California	United States
6	Research Site	San Diego	California	United States
7	Research Site	San Jose	California	United States
8	Research Site	Santa Rosa	California	United States
9	Research Site	Walnut Creek	California	United States
10	Research Site	Danbury	Connecticut	United States
11	Research Site	Melbourne	Florida	United States
12	Research Site	Ocala	Florida	United States
13	Research Site	Pompano Beach	Florida	United States
14	Research Site	Port Charlotte	Florida	United States
15	Research Site	Punta Gorda	Florida	United States
16	Research Site	Tampa	Florida	United States
17	Research Site	Weston	Florida	United States
18	Research Site	Atlanta	Georgia	United States
19	Research Site	Decatur	Georgia	United States
20	Research Site	Duluth	Georgia	United States
21	Research Site	Lawrenceville	Georgia	United States
22	Research Site	Honolulu	Hawaii	United States
23	Research Site	Arlington Heights	Illinois	United States
24	Research Site	Maywood	Illinois	United States
25	Research Site	Fort Wayne	Indiana	United States
26	Research Site	Des Moines	Iowa	United States
27	Research Site	Louisville	Kentucky	United States
28	Research Site	Marrero	Louisiana	United States
29	Research Site	Shreveport	Louisiana	United States
30	Research Site	South Weymouth	Massachusetts	United States
31	Research Site	Worcester	Massachusetts	United States
32	Research Site	Ann Arbor	Michigan	United States
33	Research Site	East Lansing	Michigan	United States
34	Research Site	Robbinsdale	Minnesota	United States
35	Research Site	Kansas City	Missouri	United States
36	Research Site	Omaha	Nebraska	United States
37	Research Site	Reno	Nevada	United States
38	Research Site	Edison	New Jersey	United States
39	Research Site	Holmdel	New Jersey	United States
40	Research Site	Morristown	New Jersey	United States
41	Research Site	Ridgewood	New Jersey	United States
42	Research Site	Summit	New Jersey	United States
43	Research Site	Manhasset	New York	United States
44	Research Site	Schenectady	New York	United States
45	Research Site	Durham	North Carolina	United States
46	Research Site	Winston Salem	North Carolina	United States
47	Research Site	Akron	Ohio	United States
48	Research Site	Cleveland	Ohio	United States
49	Research Site	Toledo	Ohio	United States
50	Research Site	Youngstown	Ohio	United States
51	Research Site	Oklahoma City	Oklahoma	United States
52	Research Site	Abington	Pennsylvania	United States
53	Research Site	Danville	Pennsylvania	United States
54	Research Site	Hershey	Pennsylvania	United States
55	Research Site	Philadelphia	Pennsylvania	United States
56	Research Site	Pittsburgh	Pennsylvania	United States
57	Research Site	Bristol	Tennessee	United States
58	Research Site	Memphis	Tennessee	United States
59	Research Site	Houston	Texas	United States
60	Research Site	Lubbock	Texas	United States
61	Research Site	Virginia Beach	Virginia	United States
62	Research Site	Olympia	Washington	United States
63	Research Site	Madison	Wisconsin	United States
64	Research Site	Marshfield	Wisconsin	United States