NCT01847014终止3 期
AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
Actelion2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2013年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incident Rate of Adverse Events (AEs).
研究概览
简要总结
SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Patients with PAH who completed study AC-055-401
- •Women of childbearing potential must:
- •Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
- •Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.
排除标准
- •Patients who prematurely discontinued study drug in study AC-055-401
- •Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
- •Known hypersensitivity to macitentan or its excipients or drugs of the same class
研究组 & 干预措施
Macitentan
Experimental
Macitentan tablet, dose of 10 mg, once daily.
干预措施: Macitentan (Drug)
结局指标
主要结局
Incident Rate of Adverse Events (AEs).
时间窗: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.
次要结局
未报告次要终点
研究者
研究点 (2)
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