EUCTR2009-014992-31-IT
进行中（未招募）
1 期
ong-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON-O
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Actelion Pharmaceuticals Ltd
- 入组人数
- 670
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC\-065A302\. \- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 447
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 223
排除标准
- •\- Any major violation of protocol AC\-065A302\. \- 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 ACT\-293987 or any of the excipients.
结局指标
主要结局
未指定
相似试验
已完成
不适用
Prospective, open-label, single arm study to assess the pharmacodynamics effects and safety of one dose of 30 mg ulipristal acetate (UPA) taken before dominant follicle selectioNL-OMON42809HRA Pharma30
已完成
不适用
Effect of Takrarishta on Irritable Bowl SyndromeHealth Condition 1: K582- Mixed irritable bowel syndromeCTRI/2024/05/067261Bhimashankar Ayurved College12
进行中（未招募）
1 期
Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensioEUCTR2009-014992-31-NLActelion Pharmaceuticals Ltd1,150
进行中（未招募）
1 期
Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensioThe intended indication is Pulmonary Arterial HypertensionMedDRA version: 19.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2009-014992-31-DEActelion Pharmaceuticals Ltd1,150
进行中（未招募）
1 期
Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensioThe intended indication is Pulmonary Arterial HypertensionMedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2009-014992-31-PLActelion Pharmaceuticals Ltd1,150