NL-OMON41513已完成3 期
ong-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL: Prostacyclin (PGI2) Receptor agonist In PAH Open Label
Actelion Pharmaceuticals0 个研究点目标入组 24 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
- 24
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 who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study).
- •- Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after study drug discontinuation.
排除标准
- •- Pediatric patients (i.e., < 18 years of age).
- •- Patients who are not able to perform the Visit 1 of AC-065A303/GRIPHON OL within 2 weeks (i.e., 14 days) of the last visit in AC-065A302/GRIPHON.
- •- Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
- •- Females who plan to become pregnant during the study, or are breastfeeding.
- •- 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 selexipag (ACT-293987) or any of the excipients.
研究者
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