NCT00748566终止4 期
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
研究概览
简要总结
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.
详细描述
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.
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 Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
时间窗: Endpoint (premature discontinuation or Week 52)
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.
次要结局
- Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52(Baseline, Week 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 Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in the Physical Activity Index Score at Week 28 and 52(Baseline, Week 28, 52)
- Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Weight at Week 4,12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52(Baseline, Week 12, 28, 52)
- Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52(Baseline, Week 28, 52)
- Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- 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)
- Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Change From Baseline in Insulin Level at Week 4, 12, 28 and 52(Baseline, Week 4, 12, 28, 52)
- Clinical Global Impression-Improvement (CGI-I) Scale Score(Endpoint (premature discontinuation or Week 52))
- Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52(Baseline, Week 28, 52)
- Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52(Baseline, Week 28, 52)
- Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52(Baseline, Week 28, 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(Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52)
研究者
研究点 (1)
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