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One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome

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NCT00748566

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia and Disorders With Psychotic Features
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject must present at least 2 of the following risk factors of MS at screening:
Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated
triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: ( 5.6 mmol/L.

- According to the clinical judgment of the investigator, the risk factors for MS have
developed in close temporal relationship to starting an antipsychotic medication.

- Substitution to a less metabolically disruptive antipsychotic medication is
considered.

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

- Subjects with contraindication(s) to the use of Ziprasidone according to Canadian
prescribing information.

- Subjects with a history of treatment resistance.

- Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing
dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate
or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that
may confound the evaluation of the study drug.

- Body mass index ? 40 at baseline.

NCT00748566
Pfizer
Terminated
One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome

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One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
A One-Year, Phase IV, Open-Label, Non-Comparative Trial Of The Effect Of Ziprasidone HCL On Metabolic Syndrome Risk Factors In Patients With Psychotic Disorders
The purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.
The trial was terminated prematurely on May 24, 2012, due to changes in organizational strategy and resources. The decision to terminate the trial was not based on any safety or efficacy concerns.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia and Disorders With Psychotic Features
Drug: Ziprasidone HCL (oral)
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
Other Name: Zeldox, Geodon
Experimental: Active treatment (switch to oral Ziprasidone)
Intervention: Drug: Ziprasidone HCL (oral)
Chue P, Mandel FS, Therrien F. The effect of ziprasidone on metabolic syndrome risk factors in subjects with schizophrenia: a 1 year, open-label, prospective study. Curr Med Res Opin. 2014 Jun;30(6):997-1005. doi: 10.1185/03007995.2014.898139. Epub 2014 Mar 17.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
172
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must present at least 2 of the following risk factors of MS at screening: Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated triglycerides (TGs): ?1.7 mmol/L (?150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ? 5.6 mmol/L.
  • According to the clinical judgment of the investigator, the risk factors for MS have developed in close temporal relationship to starting an antipsychotic medication.
  • Substitution to a less metabolically disruptive antipsychotic medication is considered.

Exclusion Criteria:

  • Subjects with contraindication(s) to the use of Ziprasidone according to Canadian prescribing information.
  • Subjects with a history of treatment resistance.
  • Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug.
  • Body mass index ? 40 at baseline.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00748566
A1281173
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

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

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