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Aripiprazole Oral Acceptability Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00101569
First Posted: January 13, 2005
Last Update Posted: November 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aripiprazole Oral Acceptability Trial

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable patients currently receiving aripiprazole or other antipsychotic medications.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00101569     History of Changes
Other Study ID Numbers: CN138-091
First Submitted: January 12, 2005
First Posted: January 13, 2005
Last Update Posted: November 8, 2013
Last Verified: July 2008

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs