Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
This study has been completed.
Information provided by:
First received: January 12, 2004
Last updated: January 3, 2013
Last verified: January 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- Global disability on modified Rankin scale at 90 days
Secondary Outcome Measures:
- NIH stroke scale
- Barthel Index
- Stroke Impact Scale
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075959
||AstraZeneca NXY-059 Medical Science Director, MD
No publications provided
History of Changes
|Other Study ID Numbers:
||SA-NXY-0012, 0012, CHANT
|Study First Received:
||January 12, 2004
||January 3, 2013
||United States: Food and Drug Administration
Keywords provided by AstraZeneca:
cerebral vascular accident
Intracerebral Hemorrhage (ICH)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs