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ICTUS Study: International Citicoline Trial on Acute Stroke

NCT00331890 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2298

Last updated 2012-06-20

No results posted yet for this study

Summary

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

Conditions

  • Acute Stroke
  • Cerebral Infarction

Interventions

DRUG

Citicoline

1g/12h iv during 3 days and then orally until complete 6 weeks of treatment

DRUG

Placebo

As active drug

Sponsors & Collaborators

  • Ferrer Internacional S.A.

    lead INDUSTRY

Principal Investigators

  • Antoni Dávalos, MD, PhD · Hospital Universitari Germans Trias i Pujol, Badalona (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Germany
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00331890 on ClinicalTrials.gov