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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Sora, Frosinone, 03039 Italy
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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 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 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

NCT00139737
Pfizer
Completed
Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

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Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia
Open Extension Study Evaluating the Safety and Tolerability of Oral Ziprasidone in the Treatment of Subjects Who Have Successfully Completed a Previous Ziprasidone Study
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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
Drug: Ziprasidone
20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
Other Name: Geodon, Zeldox
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
344
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00139737
A1281061
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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