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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

This study is currently recruiting participants.
Verified by Eisai Medical Research Inc., September 2007

Sponsored by: Eisai China Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00474409
  Purpose

To investigate efficacy and safety of Betahistine Mesilate in the treatment of patients with vertigo caused by posterior circulation infarction.


Condition Intervention Phase
Vertigo
Drug: Merislon
Phase IV

MedlinePlus related topics:   Dizziness and Vertigo   

ChemIDplus related topics:   Betahistine    Betahistine dihydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Changes of EEV scale in 4 weeks.

Secondary Outcome Measures:
  • The duration time of the vertigo symptom.

Estimated Enrollment:   360
Study Start Date:   May 2007

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

Clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474409

Contacts
Contact: Yin     86-21-62883118    

Locations
China
Beijing Tiantan Hospital     Recruiting
      Beijing, China, 100050
Beijing Hospital     Recruiting
      Beijing, China, 100730
Shanghai Huashan Hospital     Recruiting
      Shanghai, China, 200040
Shanghai Renji Hospital     Recruiting
      Shanghai, China, 20001

Sponsors and Collaborators
Eisai China Inc.

Investigators
Principal Investigator:     Wang Yong Jun     Beijing Tiantan Hospital    
  More Information

Study ID Numbers:   MRS-CHN-001
First Received:   May 3, 2007
Last Updated:   September 11, 2007
ClinicalTrials.gov Identifier:   NCT00474409
Health Authority:   China: State Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:
Vertigo  
Posterior circulation infarction  

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Betahistine
Ischemia
Vestibular Diseases
Brain Diseases
Ear Diseases
Cerebrovascular Disorders
Vertigo
Histamine
Signs and Symptoms
Necrosis
Histamine phosphate
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Histamine Agents
Cardiovascular Agents
Pharmacologic Actions
Pathologic Processes
Histamine Agonists
Therapeutic Uses
Cardiovascular Diseases
Labyrinth Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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