EUCTR2010-021572-29-IT进行中（未招募）不适用
An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1.Have participated in and complied, to the best of their ability, with the protocol for AMB112529 and have met one of the following:
- •a.Completed the Week 24 visit in AMB112529;
- •b.Required additional targeted treatment for PAH due to inadequate response to the current treatment or worsening of their clinical condition prior to week 24 in AMB112529;
- •c.Required reduction in dose of baseline targeted treatment for PAH after ambrisentan was added to the treatment regimen;
- •d.In the opinion of the investigator, continued treatment with ambrisentan is warranted.
- •2.A female is eligible to participate in this study, as assessed by the investigator, if she is of:
- •a.Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- •b.Child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug (reliable methods of contraception are listed in Appendix 2).
- •3.Subject or subject’s legal guardian is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1.Subjects who were withdrawn from ambrisentan in Study AMB112529;
- •2.Subjects who did not comply with the protocol in Study AMB112529;
- •3.Female subjects who are pregnant or breastfeeding;
- •4.Subjects with severe renal impairment (estimated creatinine clearance <30 mL/min assessed within the previous 45 days) at the point of transition from Study AMB112529 into this study;
- •5.Subject with clinically significant fluid retention in the opinion of the investigator;
- •6.Subject with clinically significant anaemia in the opinion of the investigator;
- •7.Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB112529.
研究者
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