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Sponsored by: |
Ferrer Internacional S.A. |
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Information provided by: | Ferrer Internacional S.A. |
ClinicalTrials.gov Identifier: | NCT00331890 |
Citicoline is a safe drug approved in some countries for the treatment of acute ischemic stroke. The drug has shown some evidence of efficacy in a pooled analysis, based on four clinical trials done in USA with oral citicoline.The purpose of the study is confirm the results obtained in the pooled analysis, that is, evidence of efficacy in the treatment of acute ischemic stroke
Condition | Intervention | Phase |
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Acute Stroke Cerebral Infarction |
Drug: Citicoline Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Citicoline in the Treatment of Acute Ischemic Stroke. An International Randomized Multicenter Placebo-Controlled Study |
Estimated Enrollment: | 2600 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Experimental
Receives active drug
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Drug: Citicoline
1g/12h iv during 3 days and then orally until complete 6 weeks of treatment
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Placebo: Placebo Comparator
Receives a placebo
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Drug: Placebo
As active drug
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julio J Secades, MD, PhD | +34936003837 | jsecades@ferrergrupo.com |
Contact: Savion Gropper, MD | +34935093243 | sgropper-research@ferrergrupo.com |
Study Chair: | Antoni Dávalos, MD, PhD | Hospital Universitari Germans Trias i Pujol, Badalona (Spain) |
Responsible Party: | Ferrer Group ( Julio J Secades ) |
Study ID Numbers: | GF-ICTUS-04 |
Study First Received: | May 30, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00331890 |
Health Authority: | Spain: Spanish Agency of Medicines; Portugal: National Pharmacy and Medicines Institute |
Neuroprotection Acute ischemic stroke Cerebral infarction |
Choline Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Necrosis Cytidine Diphosphate Choline Brain Ischemia Brain Infarction Infarction |
Nootropic Agents Pathologic Processes Therapeutic Uses Nervous System Diseases |
Cardiovascular Diseases Central Nervous System Agents Pharmacologic Actions |