NCT03359889已完成不适用
Post Marketing Surveillance Program of Praxbind Use in India.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
研究概览
简要总结
This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding
- •Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
排除标准
- •Participation in a PraxbindTM clinical trial
研究组 & 干预措施
patients administered with PraxbindTM
干预措施: PraxbindTM (Drug)
结局指标
主要结局
Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
时间窗: Up to 7 days following treatment.
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
次要结局
- Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding(Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Praxbind data collection program after marketing in IndiaCTRI/2018/08/015462Boehringer Ingelheim India Private Ltd5
已完成
不适用
Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical PracticeWet Age-related Macular DegenerationNCT03290794Bayer100
已完成
不适用
An Observational Study For AmbrisentanHypertension, PulmonaryNCT00679224GlaxoSmithKline800
已完成
不适用
Samsca Post Marketing Surveillance StudyHypervolemic and Euvolemic HyponatremiaNCT02722863Korea Otsuka Pharmaceutical Co., Ltd.908
已完成
不适用
Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)DiabetesDiabetes Mellitus, Type 2NCT02321878Novo Nordisk A/S1,092