临床试验/NCT01113541

NCT01113541终止3 期

A One-year, Phase III, Open-label, Non-comparative Trial of the Effect of Ziprasidone HCl on Metabolic Syndrome Risk Factors in Patients With Bipolar Disorder

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.10 个研究点分布在 1 个国家目标入组 13 人开始时间: 2010年7月最近更新: 2021年3月3日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方
入组人数: 13
试验地点: 10
主要终点: Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

详细描述

The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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.

研究组 & 干预措施

Active treatment (switch to oral Ziprasidone)

Experimental

干预措施: Ziprasidone HCL (oral) (Drug)

结局指标

主要结局

Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation

时间窗: Week 52 or Early Termination

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

次要结局

Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides(Baseline, Week 4, Week 12, Week 52)
Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System(Baseline, Week 4, Week 52)
Change From Baseline in Leptin(Baseline, Week 52 or Early Termination)
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)(Baseline, Week 52)
Metabolic Syndrome (MS) Prevalence(Baseline through Week 52)
Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors(Baseline through Week 52)
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)(Baseline, Week 4, Week 12, Week 52)
Change From Baseline in Insulin Levels(Baseline, Week 52 or Early Termination)
Change From Baseline in Apolipoprotein B (ApoB) Levels(Baseline, Week 52 or Early Termination)
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose(Baseline, Week 4, Week 12, Week 52)
Change From Baseline in Body Mass Index (BMI)(Baseline, Week 4, Week 12, Week 52 or Early Termination)
Clinical Global Impression - Improvement (CGI-I) Subscale Score(Week 52 or Early Termination)
Change From Baseline in Drug Attitude Inventory (DAI)(Week 28, Week 52 or Early Termination)
Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor(Baseline through Week 52)
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference(Baseline, Week 4, Week 12, Week 52)
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure(Baseline, Week 4, Week 12, Week 52)
Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)(Baseline, Week 4, Week 52 or Early Termination)
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score(Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination)
Change From Baseline in Young Mania Rating Scale (YMRS)(Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination)
Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score(Baseline, Week 28, Week 52 or Early Termination)
Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])(Baseline, Week 1 through Week 52 or Early Termination)
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels(Baseline, Week 52 or Early Termination)
Change From Baseline in Weight(Baseline, Week 4, Week 12, Week 52 or Early Termination)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, Week 52 or Early Termination)
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale(Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination)
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)(Baseline, Week 28, Week 52 or Early Termination)
Change From Baseline in EuroQoL Index (EQ-I)(Baseline, Week 28, Week 52 or Early Termination)
Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale(Baseline, Week 28, Week 52 or Early Termination)
Change From Baseline in Physical Activity Index(Baseline, Week 28, Week 52 or Early Termination)

研究者

发起方

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

申办方类型

Industry

责任方

Sponsor

研究点 (10)

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