ID

29791

Description

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Investigational Product.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Keywords

Versions (1)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 19, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

English

Investigational Product

1 forms  
Record investigational product and any changes to investigational product below:
Description

Record investigational product and any changes to investigational product below:

Alias
UMLS CUI-1
C0304229
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Unit dose
Description

Unit dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C0869039
mg
Number of tablets dispensed
Description

Number of tablets dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Number of tablets returned
Description

Number of tablets returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Did the subject miss more than 3 consecutive days?
Description

Missed days

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1321605
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Similar models

Investigational Product

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Record investigational product and any changes to investigational product below:
C0304229 (UMLS CUI-1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Unit dose
Item
Unit dose
float
C0869039 (UMLS CUI [1])
Number of tablets dispensed
Item
Number of tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Number of tablets returned
Item
Number of tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item
Did the subject miss more than 3 consecutive days?
text
C0304229 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Missed days
Code List
Did the subject miss more than 3 consecutive days?
CL Item
Yes (Y)
CL Item
No (N)
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