Not Signed In -
Phenylephrine and Guaifenesin Capsules |
Deconsal II; Entex ER; Entex LA; Guaifed; Guaifed-PD |
Clinical Trial: Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
This study is not yet open for patient recruitment.
Verified by Pfizer December 2005
|
Purpose
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)
| Condition | Intervention | Phase |
|---|---|---|
| Bipolar Disorder | Drug: Ziprasidone oral capsules | Phase III |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: 26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Further study details as provided by Pfizer:
Primary Outcomes: Safety assessments, including adverse events, electrocardiographic assessments, physical exam, and laboratory measures
Secondary Outcomes: Special safety assessments, including cognitive, psychiatric, movement disorder, and functional outcomes
Expected Total Enrollment: 148
Secondary Outcomes: Special safety assessments, including cognitive, psychiatric, movement disorder, and functional outcomes
Expected Total Enrollment: 148
Study start: December 2005
Eligibility
Ages Eligible for Study: 10 Years - 17 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety
Exclusion Criteria:
- Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00265330
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A1281133
Last Updated: December 13, 2005
Record first received: December 12, 2005
ClinicalTrials.gov Identifier: NCT00265330
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 13, 2005
Record first received: December 12, 2005
ClinicalTrials.gov Identifier: NCT00265330
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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