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Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00139737
Recruitment Status : Completed
First Posted : August 31, 2005
Results First Posted : July 14, 2010
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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Brief Summary:
To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ziprasidone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study
Study Start Date : March 2002
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Intervention Details:
  • Drug: Ziprasidone
    20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
    Other Name: Geodon, Zeldox

Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 72 months ]
    All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have successfully completed a ziprasidone clinical study
  • Patients not hospitalised in an acute psychiatric service
  • Written, informed consent to participation.
  • Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued

Exclusion Criteria:

Psychiatric:

  • Subjects at immediate risk of committing harm to self or others
  • Subjects requiring concurrent treatment with non-study antipsychotic agents
  • Subjects requiring treatment with antidepressants or mood stabilizers
  • General:
  • Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
  • Acute or chronic heart disease
  • Clinically significant ECG abnormalities
  • Subjects with QTc >= 500 msec (subjects with QTc >= 450 msec and < 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved)
  • Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
  • Subjects with serum K+ or Mg++ outside the normal range
  • Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
  • Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit)
  • Pregnant or lactating women
  • Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
  • Subjects unable or unlikely to follow the study protocol
  • Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
  • Known hypersensitivity to ziprasidone or lactose
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139737


Locations
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Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00139737    
Other Study ID Numbers: A1281061
First Posted: August 31, 2005    Key Record Dates
Results First Posted: July 14, 2010
Last Update Posted: March 3, 2021
Last Verified: March 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Open-label extension Ziprasidone study in Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents