NCT02126943已完成不适用
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Actelion1 个研究点 分布在 1 个国家目标入组 2,686 人开始时间: 2014年4月30日最近更新:
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
- 发起方
- 入组人数
- 2,686
- 试验地点
- 1
- 主要终点
- To estimate incidence rates for specified outcomes.
研究概览
简要总结
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
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 newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
排除标准
- •Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.
- •Patients enrolled in any ongoing clinical trials
研究组 & 干预措施
Opsumit (macitentan)
10 mg tablets
干预措施: Opsumit (macitentan) (Drug)
结局指标
主要结局
To estimate incidence rates for specified outcomes.
时间窗: 1 year
Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death.
次要结局
- To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.(1 year)
研究者
研究点 (1)
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