NCT02680665已完成不适用
AMEPAROMO CAPSULES 250 MG DRUG USE INVESTIGATION
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 120
- 主要终点
- Number of Participants With Adverse Drug Reactions
研究概览
简要总结
This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
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
- 15 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with no history of using this product
排除标准
- •No exclusion criteria are set out in this study.
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: 38 days at maximum
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician.
次要结局
- Proportion of Cyst Negative(10 days + 3 months at maximum)
- Overall Clinical Response Rate(10 days at maximum)
研究者
相似试验
已完成
2 期
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type PsoriasisPsoriasisPsoriasis ArthropaticaPsoriatic ArthritisNCT01988103Amgen254
已完成
2 期
Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisNCT00706147University of Miami38
已完成
2 期
A Study of Amolimogene (ZYC101a) in Patients With High Grade Cervical Intraepithelial Lesions of the Uterine CervixUterine Cervical DysplasiaNCT00264732Eisai Inc.251
撤回
2 期
Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)Ebola Virus DiseaseNCT02307591Emergency NGO Onlus
已完成
1 期
Study of ARO-MMP7 Inhalation Solution in Healthy Participants and Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT05537025Arrowhead Pharmaceuticals105