AZILECT Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,021
- 试验地点
- 1
- 主要终点
- Number of Participants Who Had One or More Adverse Events
研究概览
简要总结
The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.
详细描述
The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease.
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000.
This multi-center observational trial will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease should be surveyed.
排除标准
- •Participants who have contraindications on package insert of rasagiline.
研究组 & 干预措施
Rasagiline 1 mg
Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
干预措施: Rasagiline (Drug)
结局指标
主要结局
Number of Participants Who Had One or More Adverse Events
时间窗: 24 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants Who Had One or More Adverse Drug Reactions
时间窗: 24 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
次要结局
- Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)(Baseline, Up to Month 24 (Final Assessment Point))