One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia and Disorders With Psychotic Features
Intervention: Ziprasidone HCL (oral) (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
Secondary outcome: Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52Percentage of Participants With Metabolic Syndrome (MS) Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change From Baseline in Weight at Week 4,12, 28 and 52 Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 Change From Baseline in the Physical Activity Index Score at Week 28 and 52 Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 Clinical Global Impression-Improvement (CGI-I) Scale Score Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, Calgary, Alberta T2N 4Z6, Canada
Pfizer Investigational Site, Calgary, Alberta T2N 2T9, Canada
Pfizer Investigational Site, Medicine Hat, Alberta T1B 4E7, Canada
Pfizer Investigational Site, Medicine Hat, Alberta T1A 4C2, Canada
Pfizer Investigational Site, Red Deer, Alberta T4N 1T6, Canada
Pfizer Investigational Site, Penticton, British Columbia V2A 4M4, Canada
Pfizer Investigational Site, Victoria, British Columbia V8R 4Z3, Canada
Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada
Pfizer Investigational Site, Winnipeg, Manitoba R3E 3N4, Canada
Pfizer Investigational Site, Winnipeg, Manitoba R3K 2E2, Canada
Pfizer Investigational Site, Winnipeg, Manitoba R3P 0N5, Canada
Pfizer Investigational Site, Bathurst, New Brunswick E2A 2Z6, Canada
Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1E 4J8, Canada
Pfizer Investigational Site, Halifax, Nova Scotia B3H 2E2, Canada
Pfizer Investigational Site, Sydney, Nova Scotia B1P 1C6, Canada
Pfizer Investigational Site, Sydney, Nova Scotia B1P 1E1, Canada
Pfizer Investigational Site, Burlington, Ontario L7R 4E2, Canada
Pfizer Investigational Site, Chatham, Ontario N7L 1B7, Canada
Pfizer Investigational Site, Kingston, Ontario K7L 4X3, Canada
Pfizer Investigational Site, London, Ontario N6A 4G5, Canada
Pfizer Investigational Site, Markham, Ontario L6B 1A1, Canada
Pfizer Investigational Site, Mississauga, Ontario L5M 4N4, Canada
Pfizer Investigational Site, Ottawa, Ontario K1H 8K7, Canada
Pfizer Investigational Site, Sudbury, Ontario P3E 1X3, Canada
Pfizer Investigational Site, Toronto, Ontario M6J 1H4, Canada
Pfizer Investigational Site, Toronto, Ontario M5T 1R8, Canada
Pfizer Investigational Site, Windsor, Ontario N9C 3Z4, Canada
Pfizer Investigational Site, Montreal, Quebec H1N 3M5, Canada
Pfizer Investigational Site, Montreal, Quebec H1N 3V2, Canada
Pfizer Investigational Site, Montreal, Quebec H3A 1A1, Canada
Pfizer Investigational Site, Verdun, Quebec H4H 1R3, Canada
Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 3H3, Canada
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2008
Last updated: April 29, 2013
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