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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 52

Percentage 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

Page last updated: August 20, 2015

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