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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 30, 2015
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs