Status:
TERMINATED
One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia and Disorders With Psychotic Features
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 a...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00748566
Start Date
December 1 2008
End Date
May 1 2012
Last Update
March 3 2021
Active Locations (32)
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1
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 2T9
2
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4Z6
3
Pfizer Investigational Site
Medicine Hat, Alberta, Canada, T1A 4C2
4
Pfizer Investigational Site
Medicine Hat, Alberta, Canada, T1B 4E7