Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
124 participants
INTERVENTIONAL
2010-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active
Lycopene
30 mg oral, daily, for 21 days
Placebo
placebo
starch
Interventions
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Lycopene
30 mg oral, daily, for 21 days
placebo
starch
Eligibility Criteria
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Inclusion Criteria
* Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
* Time from ictus \< 96 hours
Exclusion Criteria
* Non-aneurysmal SAH,
* Time from ictus \> 96 hours,
* Severe carotid atherosclerotic disease (≥70%)
* High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 28),
* Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)
19 Years
ALL
No
Sponsors
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Cambridge Theranostics Ltd
INDUSTRY
University of Cambridge
OTHER
Responsible Party
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Addenbrooke's Hospital
Principal Investigators
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Peter J Kirkpatrick, FRCS(SN)
Role: PRINCIPAL_INVESTIGATOR
Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
Locations
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Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Verghese M, Sunkara R, Shackelford L, Walker LT. Lycopene and cardiovascular diseases. In Preedy VR, Watson RR Ed. Lycopene: nutritional, medicinal and therapeutic properties. Science Publishers, New Hampshire, USA 2008.
Other Identifiers
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LASH 3
Identifier Type: -
Identifier Source: org_study_id
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