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Aripiprazole Oral Acceptability Trial

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00101569
First received: January 12, 2005
Last updated: April 7, 2011
Last verified: July 2008
History of Changes
  Purpose

The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.


Condition Intervention Phase
Schizophrenia
 Drug: Aripiprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aripiprazole Oral Acceptability Trial

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • acceptability

Estimated Enrollment: 59
Study Start Date: March 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Aripiprazole
Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).
Other Name: Abilify
Experimental: A2 Drug: Aripiprazole
Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).
Other Name: Abilify

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable patients currently receiving aripiprazole or other antipsychotic medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101569

Locations
United States, California
Local Institution
Anaheim, California, United States
Local Institution
National City, California, United States
United States, Florida
Local Institution
North Miami Beach, Florida, United States
United States, Kansas
Local Institution
Overland Park, Kansas, United States
United States, New York
Local Institution
Staten Island, New York, United States
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States
United States, Virginia
Local Institution
Falls Church, Virginia, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00101569     History of Changes
Other Study ID Numbers: CN138-091
Study First Received: January 12, 2005
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013