EUCTR2013-003489-15-IT进行中（未招募）1 期
An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled.
- •Women of childbearing potential must:
- •– have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC-055-310) and agree to perform monthly serum pregnancy tests.
- •– agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Patients who prematurely discontinued study drug in the ORCHESTRA study (AC-055-310).
- •Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN).
研究者
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