JPRN-UMIN000025158已完成3 期
A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
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
- 18years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1 Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1; 2 Initiation of an exercise program for cardio-pulmonary rehabilitation within 90 days prior to Day1or planned initiation during the study; 3 Stopped receiving any PAH chronic therapy within 60 days prior to Day 1; 4 Stopped receiving any PAH chronic therapy within 60 days prior to Day 1 Received a dose of prednisone 20 mg day (or equivalent dose if other corticosteroid) within 30 days prior to Day 1; 5 Received intravenous or subcutaneous prostacyclin/prostacyclin analogues within 90 days prior to Day 1; 6 Received intravenous inotropes within 30 days prior to Day 1; 7 Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) 160 mm Hg or sitting diastolic BP > 100 mm Hg during Screening after a period of rest 8 Has systolic BP 90 mm Hg during Screening after a period of rest 9 Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following: a Congenital or acquired valvular disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension; b Pericardial constriction; c Restrictive or congestive cardiomyopathy; d Left ventricular ejection fraction 40% per echocardiogram (ECHO) within 90 days of Day 1; e Symptomatic coronary artery disease within the last 3 years 10 Acutely decompensated heart failure within 30 days prior to Day 1, per investigator assessment 11 Has more than two of the following clinical risk factors for left ventricular diastolic dysfunction: a Age 65 years; b BMI 30 kgm2 c History of systemic hypertension; d History of type 2 diabetes; e History of atrial fibrillation etc
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