Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- Safety: - adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms, and other
研究概览
简要总结
This is a multinational, multicenter, open-label, flexible-dose, extension study in patients with schizophrenia. The total study duration is 53 weeks: a no-drug screening period of up to 7 days followed by 48 weeks of open-label cariprazine treatment and a 4-week safety follow-up period. The safety assessments include adverse events, clinical laboratory parameters, vital signs, electrocardiogram, ophthalmologic evaluation, extrapyramidal measures, and suicidality. Spontaneous plasma samples will be collected for pharmacokinetic evaluation. Additional outcome measures include Positive and Negative Syndrome Scale, Clinical Global Impressions ? Severity, Schizophrenia Quality of Life Scale Revision 4, and Cognitive Assessments. Approximately 600 patients (approximately 150 in India) are expected to be enrolled in about 100 study centers in the US, India, and other countries. The tentative date of enrollment of first patient in India is September, 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients who are 18 to 60 years of age.
- •Patients who have provided informed consent prior to any study specific procedures.
- •Completion of the double-blind treatment period of Study RGH-MD-
- •Patients who are eligible to continue as outpatients in the opinion of the Principal Investigator.
- •Patients with normal physical examination, laboratory, vital signs, and or electrocardiogram (ECG).
- •A designated caregiver to accompany the patient at each visit and who has provided informed consent.
排除标准
- •Positive result from the blood alcohol test or urine drug screen for prohibited medications- Patients who have extrapyramidal symptoms that are not adequately controlled by anti-EPS medications in the opinion of the PI- Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events.
结局指标
主要结局
Safety: - adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms, and other
时间窗: 48 weeks
次要结局
- Pharmacokinetics- Plasma concentrations of cariprazine and its metabolites