CTRI/2010/091/000401招募中3 期
ong term single-arm open label extension study of the SERAPHIN study to assess the safety and tolerability of ACT-064992 in patients with symptomatic pulmonary arterial hypertensionAcronym SERAPHIN (OL)- Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)
Actelion Pharmaceuticals Ltd, Gewerbestrasse16 / CH-4123 Allschwil, Switzerland0 个研究点目标入组 699 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 699
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
入选标准
- •1. Signed informed consent prior to initiation of any study-mandated procedure.
- •2. Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or
- •3. 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.
- •4. Women of childbearing potential are not allowed in the study (in India)
排除标准
- •1. Any major violation of protocol AC 055 302/SERAPHIN.
- •2. Women of childbearing potential, pregnant or breast-feeding.
- •3. AST and/or ALT > 3 times the upper limit of the normal range.
- •4. 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.
- •5. Known hypersensitivity to ACT 064992 or any of the excipients.
研究者
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