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

NCT00748566 | Terminated Phase 4 Results

• 1 other identifier: A1281173
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 32

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.

Conditions

Schizophrenia and Disorders With Psychotic Features

Keywords

Ziprasidone; metabolic syndrome; risk factors; schizophrenia; psychotic disorders.

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)

  MS risks factors: elevated (el) waist, men:\>=102 centimeters(cm), women:\>=88 cm (Asian origin:\>=90 cm in men, \>=80 cm in women); el triglycerides: \>=1.7 millimoles per liter (mmol/L) (\>=150 milligram per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C), men:\<1.03 mmol/L (\<40 mg/dL), women:\<1.3 mmol/L (\<50 mg/dL); el fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP\>=130 millimeters of mercury (mmHg) and/or DBP\>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.

  Endpoint (premature discontinuation or Week 52)

Secondary Outcomes (24)

• Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52

  Baseline, Week 4, 12, 28, 52

• Percentage of Participants With Metabolic Syndrome (MS)

  Baseline, Week 4, 12, 28, 52

• Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52

  Week 4, 12, 28, 52

• Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)

  Baseline, Week 4, 12, 28, 52

• Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52

  Baseline, Week 4, 12, 28, 52

Study Arms (1)

Active treatment (switch to oral Ziprasidone)

EXPERIMENTAL

Drug: Ziprasidone HCL (oral)

Interventions

Ziprasidone HCL (oral) DRUG

Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.

Also known as: Zeldox, Geodon

Active treatment (switch to oral Ziprasidone)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (32)

Pfizer Investigational Site

Calgary, Alberta, T2N 2T9, Canada

Location

Pfizer Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

Location

Pfizer Investigational Site

Medicine Hat, Alberta, T1A 4C2, Canada

Location

Pfizer Investigational Site

Medicine Hat, Alberta, T1B 4E7, Canada

Location

Pfizer Investigational Site

Red Deer, Alberta, T4N 1T6, Canada

Location

Pfizer Investigational Site

Penticton, British Columbia, V2A 4M4, Canada

Location

Pfizer Investigational Site

Victoria, British Columbia, V8R 4Z3, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 3N4, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3K 2E2, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3P 0N5, Canada

Location

Pfizer Investigational Site

Bathurst, New Brunswick, E2A 2Z6, Canada

Location

Pfizer Investigational Site

St. John's, Newfoundland and Labrador, A1E 4J8, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Pfizer Investigational Site

Sydney, Nova Scotia, B1P 1C6, Canada

Location

Pfizer Investigational Site

Sydney, Nova Scotia, B1P 1E1, Canada

Location

Pfizer Investigational Site

Burlington, Ontario, L7R 4E2, Canada

Location

Pfizer Investigational Site

Chatham, Ontario, N7L 1B7, Canada

Location

Pfizer Investigational Site

Greater Sudbury, Ontario, P3E 1X3, Canada

Location

Pfizer Investigational Site

Kingston, Ontario, K7L 4X3, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4G5, Canada

Location

Pfizer Investigational Site

Markham, Ontario, L6B 1A1, Canada

Location

Pfizer Investigational Site

Mississauga, Ontario, L5M 4N4, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1H 8K7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5T 1R8, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M6J 1H4, Canada

Location

Pfizer Investigational Site

Windsor, Ontario, N9C 3Z4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1N 3M5, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H1N 3V2, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3A 1A1, Canada

Location

Pfizer Investigational Site

Verdun, Quebec, H4H 1R3, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

Related Publications (1)

• 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.

  PMID: 24568177 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Metabolic Syndrome; Schizophrenia; Psychotic Disorders

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The study was prematurely terminated by sponsor due to changes in organizational strategy and resources, not due to safety concerns.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 3, 2021
• Results First Posted: June 19, 2013

Record last verified: 2021-03

Locations

CA (32)