NCT02759419已完成4 期
An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 18
- 主要终点
- Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
研究概览
简要总结
To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have completed the main study phase and are still being treated with riociguat (either while still being on treatment with the respective study drug or by commercial means with Adempas) and who, in the opinion of the investigator, are expected to continue to have an overall positive benefit/risk from continuing treatment.
- •Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the informed consent form and 30 days after the last administration of study drug.
排除标准
- •Ongoing serious adverse event (SAE) from originating study that is assessed as related to riociguat
- •Pregnant women or breast-feeding women
- •Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat Investigators's Brochure
- •Concomitant participation in another clinical study with the study drug
- •Patients with pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
研究组 & 干预措施
BAY63-2521
Experimental
Single-arm, uncontrolled
干预措施: Adempas (Riociguat, BAY63-2521) (Drug)
结局指标
主要结局
Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
时间窗: Up to approx. 3 years
次要结局
未报告次要终点
研究者
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