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

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NCT00748566

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Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 2T9, Canada
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Contact
1-800-718-1021
[email protected]
Related Links

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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: <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
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.

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Schizophrenia and Disorders With Psychotic FeaturesOne-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome NCT00748566
  1. Calgary, Alberta
  2. Calgary, Alberta
  3. Medicine Hat, Alberta
  4. Medicine Hat, Alberta
  5. Red Deer, Alberta
  6. Penticton, British Columbia
  7. Victoria, British Columbia
  8. Winnipeg, Manitoba
  9. Winnipeg, Manitoba
  10. Winnipeg, Manitoba
  11. Winnipeg, Manitoba
  12. Bathurst, New Brunswick
  13. St. John's, Newfoundland and Labrador
  14. Halifax, Nova Scotia
  15. Sydney, Nova Scotia
  16. Sydney, Nova Scotia
  17. Burlington, Ontario
  18. Chatham, Ontario
  19. Kingston, Ontario
  20. London, Ontario
  21. Markham, Ontario
  22. Mississauga, Ontario
  23. Ottawa, Ontario
  24. Sudbury, Ontario
  25. Toronto, Ontario
  26. Toronto, Ontario
  27. Windsor, Ontario
  28. Montreal, Quebec
  29. Montreal, Quebec
  30. Montreal, Quebec
  31. Verdun, Quebec
  32. Saskatoon, Saskatchewan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia and Disorders With Psychotic Features
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Active treatment (switch to oral Ziprasidone)
Intervention: Drug: Ziprasidone HCL (oral)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2012)		172
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2008)		230
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00748566
Other Study ID Numbers  ICMJE A1281173
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2013

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