EUCTR2010-021572-29-FR进行中（未招募）1 期
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 - Safety FU Study of Amb in 8-17yr olds
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
- 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
- •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
- •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: 66
- •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
- •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 Subjects who were withdrawn from ambrisentan in Study AMB112529;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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