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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 3, 2007 | ||||
| Last Updated Date | December 5, 2008 | ||||
| Start Date ICMJE | May 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Changes in the European Evaluation of Vertigo (EEV) scale in 4 weeks. [ Time Frame: 4 weeks ] | ||||
| Original Primary Outcome Measures ICMJE |
Changes of EEV scale in 4 weeks. [ Time Frame: 4 weeks ] | ||||
| Change History | Complete list of historical versions of study NCT00474409 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The duration of the vertigo symptom. | ||||
| Original Secondary Outcome Measures ICMJE |
The duration time of the vertigo symptom. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation | ||||
| Official Title ICMJE | A Multicenter, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation | ||||
| Brief Summary | The purpose of this study is to determine the efficacy and safety of Betahistine Mesilate in the treatment of patients with vertigo caused by Cerebral Infarction in posterior circulation. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Vertigo | ||||
| Intervention ICMJE | Drug: Merislon | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 360 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction. |
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00474409 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | MRS-CHN-001 | ||||
| Study Sponsor ICMJE | Eisai China Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eisai Inc. | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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