EUCTR2005-001967-70-GB进行中（未招募）1 期
An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
入选标准
- •·Signed informed consent by the parents or the legal representatives.
- •·Patients who completed the FUTURE 1 study.
- •·Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
- •·Male or female >= 2 and < 12 years of age at enrollment in FUTURE 2.
- •Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Intolerance to bosentan despite dose reductions.
- •·Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
- •·Pregnancy or breast-feeding.
- •·Known hypersensitivity to bosentan or any of the excipients.
- •·Premature and permanent study drug discontinuation during FUTURE 1.
研究者
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