EUCTR2008-003539-19-SK进行中（未招募）1 期
ong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 270
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
- •Patients who have completed 16 weeks of treatment in the double blind trial CHEST-1
- •Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •Patient’s participating in another clinical trial
- •Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY 63 2521 are not allowed to participate in the extension trial.
- •Pregnant women (i.e. positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy) or breast feeding women, or women with childbearing potential not using a combination of safe contraception methods throughout the study.
- •Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator or the sponsor.
- •Pertinent non compliance with the conditions for the trial or instructions by the investigator during CHEST-1 participation.
- •Patients with hypersensitivity to the investigational drug or inactive constituents.
研究者
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