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Phenylephrine and Guaifenesin Capsules |
Deconsal II; Entex ER; Entex LA; Guaifed; Guaifed-PD |
Clinical Trial: Safety and Efficacy of Ziprasidone in Adolescents With Schizophrenia
This study is not yet open for patient recruitment.
Verified by Pfizer January 2006
|
Purpose
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: Ziprasidone oral capsules | Phase III |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
Further study details as provided by Pfizer:
Primary Outcomes: Brief Psychiatric Rating Scale - Anchored
Secondary Outcomes: Positive and Negative Syndrome Scale; Clinical Global Impression scale
Expected Total Enrollment: 276
Secondary Outcomes: Positive and Negative Syndrome Scale; Clinical Global Impression scale
Expected Total Enrollment: 276
Study start: January 2006
Eligibility
Ages Eligible for Study: 13 Years - 17 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- DSM-IV criteria for schizophrenia; age 13 - 17 years
Exclusion Criteria:
- Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00257192
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1281134
Last Updated: January 5, 2006
Record first received: November 21, 2005
ClinicalTrials.gov Identifier: NCT00257192
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: January 5, 2006
Record first received: November 21, 2005
ClinicalTrials.gov Identifier: NCT00257192
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Endal Tablets (Drug Digest)
- Entex LA tablets (Drug Digest)
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