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12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients

This study has been terminated.
(See Detailed Description for Termination Reason)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159757
First received: September 8, 2005
Last updated: August 1, 2007
Last verified: August 2007

September 8, 2005
August 1, 2007
November 2003
Not Provided
  • Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score
  • Safety- Incidence and severity of the side effects
Efficacy- To assess the syndromes of the psychosis expressed as the PANSS total score Safety- Incidence and severity of the side effects
Complete list of historical versions of study NCT00159757 on ClinicalTrials.gov Archive Site
  • To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale)
  • To evaluate the influence on the body weight change.
  • To assess the subject's view on the treatment with ziprasidone
  • To assess the subject's antidepressive efficacy by Calgary and Hamilton depression scales
To assess the change of the clinical impression in CGI (Clinical Global Impression of Change scale) To evaluate the influence on the body weight change. To assess the subject's view on the treatment with ziprasidone To Assess the subject's antidepress
Not Provided
Not Provided
 
12 Week Open, Non-Comparative Switch Study Of Oral Ziprazidone In Previously Treated Schizophrenic Patients
12 Week Open Label, Multicenter, Non-Comparative Switch Study Evaluating Efficacy, Tolerability And Safety Of Oral Ziprasidone In Treatment Of Patients Suffering From Schizophrenia Who Have Already Been Treated With An Other Antipsychotic.

There has been evidence that ziprasidone is efficacious in decreasing the magnitude of both positive and negative symptoms of schizophrenia, and also effective in the treatment of depressive symptoms. It shows good tolerance with low incidence of extrapyramidal side effects and does not significantly influence body weight. As it has been shown that ziprasidone is efficacious and safe in patients who have been pretreated with other antipsychotic that has to be withdrawn either due to the side effects or not satisfied efficacy. The purpose of the study was to provide further evidence for the efficacy and safety of patients with schizophrenia and allow for psychiatrists in Hungary to gain experience with the drug before wide commercial availability.

Study was terminated due to difficulty in enrolling the targeted number of patients on March 1, 2005, last subject last visit date was Feb.16, 2005. There were no safety concerns involved in the decision to terminate the trial.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: ziprazidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
February 2005
Not Provided

Inclusion Criteria:

  • confirmed diagnosis of schizophrenia according to DSM-IV-IV from patient's medical files
  • subjects with current treatment with typical or atypical neuroleptics which should be changed

Exclusion Criteria:

  • patients with significant cardiovascular illness (recent acute myocardial infarction, uncompensated heart failure, cardiac arrhythmia)
  • in the patients' history clinically significant ECG abnormalities particularly prolongation of QT interval of more than 500 ms
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00159757
A1281122
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP