NL-OMON40079已完成3 期
ong-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT-064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-O
Actelion Pharmaceuticals0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Signed informed consent prior to initiation of any study-mandated procedure.
- •Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or
- •Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
- •Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
排除标准
- •Any major violation of protocol AC 055 302/SERAPHIN.
- •Pregnancy or breast-feeding.
- •AST and/or ALT > 3 times the upper limit of the normal range.
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
- •Known hypersensitivity to macitentan or any of the excipients.
研究者
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