Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031 - Full Text View

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: Ziprasidone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] ] [ Designated as safety issue: No ]
Change From Baseline in CGI-I at End of Study (up to 5 Years) [ Time Frame: Baseline, up to 5 years (End of Study [LOCF]) ] [ Designated as safety issue: No ]
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] ] [ Designated as safety issue: No ]
Change From Baseline in CGI-S at End of Study (up to 5 Years) [ Time Frame: Baseline, up to 5 years (End of Study [LOCF]) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With Scores on Patient Preference Scale (PPS) [ Time Frame: Baseline, up to 5 years (End of Study) ] [ Designated as safety issue: No ]
Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years) [ Time Frame: Baseline, up to 5 years (End of Study) ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	October 2001
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1	Drug: 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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Exclusion Criteria:

All other patients who do not fit the inclusion criteria as stated above.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174447

Locations

France
Pfizer Investigational Site
Avignon, France, 84000
Pfizer Investigational Site
Dole Saint Ylie, France, 39108
Pfizer Investigational Site
Lievin, France, 62800
Pfizer Investigational Site
Lyon Cedex, France, 69373
Pfizer Investigational Site
Montfavet, France, 84143
Pfizer Investigational Site
Orvault, France, 44700
Pfizer Investigational Site
Rennes, France, 35000
Pfizer Investigational Site
Saint Egreve Cedex, France, 38521
Pfizer Investigational Site
Saint Remy, France, 70160
Pfizer Investigational Site
Strasbourg, France, 67100
Pfizer Investigational Site
Toulon Cedex, France, 83056
Pfizer Investigational Site
Toulouse, France, 31200
Pfizer Investigational Site
Toulouse, France, 31000
Pfizer Investigational Site
Versailles, France, 78000

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Jul 27.

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.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00174447 History of Changes
Other Study ID Numbers:	A1281060
Study First Received:	September 12, 2005
Results First Received:	October 15, 2009
Last Updated:	November 20, 2009
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013