Aripiprazole Oral Acceptability Trial | NCT00101569

Studies
Aripiprazole Oral Acceptability Trial

NCT00101569

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Completed

Last Update Posted

Nov 8, 2013Estimated

Enrollment

Phase

Phase 3

Conditions

Schizophrenia

Interventions

Aripiprazole
Aripiprazole

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Jan 12, 2005

First Submission Date that Met QC Criteria

Jan 12, 2005

First Posted Date

Jan 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2013

Last Update Posted Date

Nov 8, 2013Estimated

Name	Class
Otsuka America Pharmaceutical	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A1	Experimental		Drug: Aripiprazole
A2	Experimental		Drug: Aripiprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).	A1

Measure	Description	Time Frame
acceptability

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable patients currently receiving aripiprazole or other antipsychotic medications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Anaheim	California		United States
Local Institution

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones

Browse Leaves

Not provided

Browse Branches

Not provided