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

Intracerebral Hemorrhage Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075959
• Other study ID #: SA-NXY-0012
• Secondary ID: 0012CHANT
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2004
• Last updated: January 3, 2013
• Start date: August 2004
• Est. completion date: January 2006

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• NXY-059

Locations

Country	Name	City	State
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Akron	Ohio
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Arlington Heights	Illinois
United States	Research Site	Atlanta	Georgia
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bristol	Tennessee
United States	Research Site	Carmichael	California
United States	Research Site	Cleveland	Ohio
United States	Research Site	Danbury	Connecticut
United States	Research Site	Danville	Pennsylvania
United States	Research Site	Decatur	Georgia
United States	Research Site	Des Moines	Iowa
United States	Research Site	Duluth	Georgia
United States	Research Site	Durham	North Carolina
United States	Research Site	East Lansing	Michigan
United States	Research Site	Edison	New Jersey
United States	Research Site	Fort Smith	Arkansas
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Holmdel	New Jersey
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Louisville	Kentucky
United States	Research Site	Lubbock	Texas
United States	Research Site	Madison	Wisconsin
United States	Research Site	Manhasset	New York
United States	Research Site	Marrero	Louisiana
United States	Research Site	Marshfield	Wisconsin
United States	Research Site	Maywood	Illinois
United States	Research Site	Melbourne	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Morristown	New Jersey
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olympia	Washington
United States	Research Site	Omaha	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pompano Beach	Florida
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Punta Gorda	Florida
United States	Research Site	Reno	Nevada
United States	Research Site	Ridgewood	New Jersey
United States	Research Site	Robbinsdale	Minnesota
United States	Research Site	Sacramento	California
United States	Research Site	San Diego	California
United States	Research Site	San Jose	California
United States	Research Site	Santa Rosa	California
United States	Research Site	Schenectady	New York
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Shreveport	Louisiana
United States	Research Site	South Weymouth	Massachusetts
United States	Research Site	Summit	New Jersey
United States	Research Site	Tampa	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Walnut Creek	California
United States	Research Site	Weston	Florida
United States	Research Site	Winston Salem	North Carolina
United States	Research Site	Worcester	Massachusetts
United States	Research Site	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global disability on modified Rankin scale at 90 days
Secondary	NIH stroke scale
Secondary	Barthel Index
Secondary	Stroke Impact Scale