NL-OMON34214撤回2 期
A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years (AMB112529) - AMB112529
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •8-17 (inclusive) years.
- •Pulmonary arterial hypertension due to
- •o idiopathic or heritable PAH
- •o secondary to connective tissue disease
- •o persistent after surgical repair of congenital heart defects (greater than 6 months prior to screening).
- •WHO class II or III.
- •In case of HIV: stable disease (se protocol for details).
- •mPAP at least 25 mmHg and PVR at least 240 dyne*sec/cm5 and PCWP or LVEDP of at most 15 mmHg.
- •Treatment naïve, without PAH medication for at least 1 month or stable background medication.
- •Females of childbearing potential: reliable method of contraception.
排除标准
- •ERA or cyclosporine A treatment.
- •Weight less than 20 kgs.
- •Previous safety or tolerability issues with PAH treatment (see protocol for details).
- •Pregnancy or breastfeeding
研究者
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