EUCTR2009-014992-31-NL进行中（未招募）1 期
ong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON O
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,150
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
- •1. Signed informed consent prior to initiation of any study-mandated procedure.
- •2. Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study).
- •3. Women of child-bearing potential1 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.
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Pediatric patients (i.e., < 18 years of age).
- •2. 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.
- •3. 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.
- •4. Severe hepatic impairment (Child-Pugh C).
- •5. Females who are pregnant or plan to become pregnant during the study, or are breastfeeding.
- •6. 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.
- •7. Known hypersensitivity to selexipag or any of the excipients.
研究者
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