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Clinical Trials/NCT00460226
NCT00460226
Completed
N/A

A Multi-centre, Observational Study to Evaluate the Incidence of Non-serious Rash in Korean Bipolar I Patients With Lamotrigine Therapy in Real World Setting

GlaxoSmithKline0 sites238 target enrollmentMarch 2007
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ConditionsBipolar Disorder
Interventionslamotrigine
Drugslamotrigine

Overview

Phase
N/A
Intervention
lamotrigine
Conditions
Bipolar Disorder
Sponsor
GlaxoSmithKline
Enrollment
238
Primary Endpoint
Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
December 2007
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

lamotrigine

there is only one group.

Intervention: lamotrigine

Outcomes

Primary Outcomes

Occurrence of non-serious rash during 12 weeks of treatment with lamotrigine in patients with bipolar I in Korea

Time Frame: 12 weeks

Secondary Outcomes

  • CGI-BP at Week 12 and occurrence of adverse events at Week 12(12 weeks)

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