Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

NCT ID: NCT00174447

Last Updated: 2021-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2008-10-31

Brief Summary

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Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Group Type EXPERIMENTAL

Ziprasidone

Intervention Type DRUG

Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

Interventions

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Ziprasidone

Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc \<= 500 msec.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Avignon, , France

Site Status

Pfizer Investigational Site

DOLE Saint YLIE, , France

Site Status

Pfizer Investigational Site

Liévin, , France

Site Status

Pfizer Investigational Site

Lyon, , France

Site Status

Pfizer Investigational Site

Montfavet, , France

Site Status

Pfizer Investigational Site

Orvault, , France

Site Status

Pfizer Investigational Site

Rennes, , France

Site Status

Pfizer Investigational Site

Saint-Égrève, , France

Site Status

Pfizer Investigational Site

Saint-Rémy, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Toulon, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Pfizer Investigational Site

Versailles, , France

Site Status

Countries

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France

References

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Geier JL, Karayal ON, Lewis M, Camm JA, Keane M, Kremer CM, Kolluri S, Reynolds R, Eng S, Strom BL. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1192-8. doi: 10.1002/pds.2185. Epub 2011 Jul 27.

Reference Type DERIVED
PMID: 21796719 (View on PubMed)

Strom BL, Faich GA, Reynolds RF, Eng SM, D'Agostino RB, Ruskin JN, Kane JM. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry. 2008 Jan;69(1):114-21. doi: 10.4088/jcp.v69n0115.

Reference Type DERIVED
PMID: 18312045 (View on PubMed)

Related Links

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Other Identifiers

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A1281060

Identifier Type: -

Identifier Source: org_study_id

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