NCT00748566

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia and Disorders With Psychotic Features

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-09-08
• Last updated: 2021-03-03
• Results posted: 2013-06-19

Locations

32 sites across 1 country: Canada