Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more ➡
Download
Standard view
Full view
of .
Add note
Save to My Library
Sync to mobile
Look up keyword
Like this
2Activity
×
0 of .
Results for:
No results containing your search query
P. 1
CAFE Study Full Protocol

CAFE Study Full Protocol

Ratings: (0)|Views: 2,132|Likes:
Published by MarkingsonCase

More info:

Categories:Business/Law
Published by: MarkingsonCase on Feb 28, 2011
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See More
See less

02/28/2011

pdf

text

original

 
TrialNumber:
50771L/0114
DateofApproval:October12,2001Revision1:August05,2002:':Revision2:.March01,2003
,RB«»
'liD
JeffreyA.Lieberman,MDDianaO.Perkins,MD,MPHJosephMcEvoy,MD.Hongbin.GuPhDRobertHamerPh0GaryKochPh0
ThisdocumentisaconfidentialcommunicationofAstraZenecaPharmaceuticalsLP(AstraZeneca).AcceptanceofthisdocumentconstitutestheagreementbytherecipientthatnounpublishedinformationcontainedhereinwillbepublishedordisclosedwithoutthepriorwrittenapprovalofAstraZeneca,exceptthatthisdocumentmaybedisclosedtoappropriateInstitutionalReviewBoardssolongastheyarerequestedtokeepitconfidential.
 
-,
EfficacyandTolerability
of
O/anzapine,QuetiapineandRispen'doneintheTreatmentofFirstEpisodePsychosis:ARandomizedDoubleBlind
52
WeekComparison.
1.BACKGROUNDANDRATJONALE......•............................................................5
2.SPECIFICAIMS7
2.1.
OVERVlEW
72.2.
PRIMARYAIM
7
2.3.
SECONDARYAIMS;,
7
3.STUDYDESIGN"'"'~..
II
9
3.1.
OVERVIEW
9.
3.2.
RATIONALEFORSTUDYDeSIGN,DOSESANDCONTROLGROUPS
9
3.2.1.Phase
1
Sf
';·3.2.2...
Phase
2
·hMt:..
g,:elirrfin?:ck_c!··..·..···..·..·
9l
ISlt
Intervals.3.2.4.Enrollment
10
3.3.
SELECTIONOFSTUDYPOPULATION
10
3.3.1.studySelectionRecord.~103.3.2.InclusionCriteria
10
3.3.3.ExclusionCriteria:·103.3.4.Discontinuation
of
SubjectsfromTreatmentorAssessment..11
3.3.4.1.CriteriaforDiscontinuation,
11
3.3.4.2.VoluntaryDiscontinuationbyaSubject
12
3.4.
TREATMENTS~
12
3.4.1.InvestigationalProducts12
3.4.1.1.DrugPackaging
&
LabelingDesign123.4.1.2.StorageandInventoryManagement..133.4.1.3.Accountability
13
3.4.2.Doses
andTreatmentRegimens
13
3.4.2.1.DosingandAdministration13.3.4.2.2.DiscussionofDosingDesign14
3.4.2.3.
ConcomitantandAdjunctiveMedication
15
3.4.3.MethodofAssigningSubjectstoTreatmentGroups
15
3.4.4.BlindingandProceduresforUnblindingtheStudy
16
3.4.4.1.MethodsforInsuringBlinding16
3.4.4.2.
MethodsforUnblindingtheStudy
16
4.STUDYMEASUREMENTSANDENDPOINTS17
4.1.
SAFETiMEASUREMENTSANDENDPOINTS
17
4.1.1.AdverseEvents:~
17
.4.1.1.1.
Definitions,
174.1.1.2.
SeriousAdverseEvents~
17
·4.1.1.3.
Oeath18
4.1.1.4.
RecordingofAdverseEvents19
4.1.1.5.
ReportingofSeriousAdverseEvents19
4.2.
MEASURESOFASSESSMENT
20
Page2
IR8QC:IcJ,.,.,
 
EfficacyandTolerabilifyofOJanzapine,QuetiapineandRispetidoneintheTreatmentofFirstEpisodePsychosis:ARandomizedDoubleBlind
52
WeekComparison
4.2.1..
RationaleforAssessmentMeasures
20
4.2.1.1.ClinicalAssessments:,.204.2.1.2.OtherClinicalOutcomes224.2.1.3.NeurocognitiveFunction(120minutebattery)22
4.2.2.QualityControl
of
ClinicalandFunctionalAssessments
23
5.STATISTICALANALYSES:245.1.
INTRODUCTION
245.2.
STUDYOBJECTIVESANDENDPOINTS
24·
5.2.1.
StudyObjectives
24
5.2.2.
PrimaryObjective
24
5.2.3.
SecondaryObjectives
245.2.4.
StudyEndpointsandEvaluations
24
5.3.
ANALYSISPOPULATIONSANDDATASETS
25
5.3.1.
Definitions
of
AnalysisPopulations
25
5.3.2.
ApplicationofAnalysisPopulations"
265.3.3..
DefinitionofAnalysisDatasets
26
5.3.4.
Application
of
theAnalysisDatasets
26
5.4.
DATAQUALITYANDASSURANCE
26
5.5.
STATISTICALCONSIDERATIONS
26
5.5.1.
GeneralStatisticalProcedures
26
5.5.2.
PatientEnrollmentandDisposition
265.5.3.
ProtocolDeviations
27
5.5.4.
Analysis
of
DemographicandOtherBaselineCharacteristics
27
5.5.4.1.PatientDemographics275.5.4.2.GeneralMedicalandPsychiatricHistory275.6.
ANALYSISOFEFFECTIVENESSDATA:
27
5.6.1.PrimaryEffectivenessParameter
27
5.6.2.
PoolingofSmallCentersforAna/ysis
27
5.6.3.Analysis
of
PrimaryEffectivenessParameter
27
5.6.3.1.CovariateAdjustment28.5.6.3.2.SubgroupAna/yses295.6.3.3.MissingDataConsiderations295.6.3.4.SecondaryEffectivenessParameters295.6.3.5.PoolingofSmallCentersforAnalysis29
5.7.
ANALYSISOFSAFETY'DATA:
30
5.7.1.AdverseEvents30
5.7.2.
DeathsandOtherSeriousAdverseEvents30
5.7.3.
VitalSigns305.7.4.LaboratoryParameters'30
5.8.
SAMPLESIZEDETERMINATION
30
6.NUMBEROFSITESANDRATEOFENROLLMENT31
".Page3
1··~·/&f,.._
7.
APPENDICES32
7.1.
(ApPENDIXA)FURTHERGUIDANCEONTHEDEFINITION
OF
ANSAE
32

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->