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Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Aripiprazole (Drug); Aripiprazole (Drug); Aripiprazole (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Summary

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Clinical Details

Official title: A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change at endpoint in schizophrenia rating scale

Secondary outcome: Clinical Global Improvement scale at endpoint and time to response

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the

past three months

Locations and Contacts

Bristol-Meyers Squibb Call Center, Wallingford, Connecticut, United States
Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: November 2003
Last updated: November 7, 2013

Page last updated: August 20, 2015

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