NCT00613756已完成不适用
Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Incidence of adverse drug reactions (ADRs
研究概览
简要总结
The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings 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
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease who have renal dysfunction with pretreatment creatinine clearance =<70mL/min or whose renal dysfunction was determined by the physician
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse drug reactions (ADRs
时间窗: up to 12 weeks
Incidence of serious adverse events (SAEs)
时间窗: up to 12 weeks
Incidence of adverse events
时间窗: up to 12 weeks
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) part III total score(change from baseline to week 12)
- Physician's overall judgement by medical interview into 4 grades (5 categories)(week 12)
- Modified Hoehn & Yahr rating scale(change from baseline to week 12)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
"Brexpiprazole (Rexulti™) Safety and Efficacy Among Filipino Patients (RAISE) - A Post Marketing Surveillance Program"SchizophreniaMajor Depressive DisorderNCT04641780Otsuka Pharmaceutical, Inc., Philippines300
招募中
不适用
A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).Chronic Leukemia MyelogenousNCT06297161Pfizer600
已完成
不适用
Survey on PD Patients With Depressive SymptomsParkinson DiseaseNCT00614575Boehringer Ingelheim1,089
已完成
不适用
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs SyndromeRestless Legs SyndromeNCT01174459Boehringer Ingelheim571
已完成
不适用
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs SyndromeRestless Legs SyndromeNCT00721279Boehringer Ingelheim549