EUCTR2012-001642-17-IT进行中（未招募）1 期
An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
GlaxoSmithKline Research & Developement Ltd0 个研究点目标入组 160 人开始时间: 2013年9月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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:
- •a) Have been randomized to the protocol for AMB115811.
- •b) Have completed the Week 16 visit in AMB115811.
- •General considerations:
- •c) Female subject of childbearing potential must agree to use 2 reliable methods
- •of contraception from the Screening Visit until study completion and for at
- •least 30 days following the last dose of Investigational Product (reliable
- •methods of contraception are described in Appendix 2). As part of the
- •consent, female subjects of childbearing potential will be informed of the risk
- •of teratogenicity and will need to be counseled 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.
- •d) Subject must agree not to participate in a clinical study involving another
- •investigational drug or device throughout this study.
- •e) Subject must be competent to understand the information given in the
- •Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
- •approved informed consent form (ICF) and must sign the form prior to the
- •initiation of any study procedures.
- •Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the Investigators Brochure and product label for PAH indication.
- •Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Subjects meeting any of the following criteria must not receive Ambrisentan, however
- •may still be followed-up as part of the study and be treated according to best clinical
- •practice as decided by the investigator:
- •1. Subject prematurely withdrew from AMB115811where IP has been stopped due
- •to safety , efficacy or any other reason at the opinion of the investigator,
- •2. Subject has a known hypersensitivity to the Investigational Products, the
- •metabolites, or formulation excipients
- •3. Female subjects who are pregnant or breastfeeding or no-longer agree to comply with using effective contraception as defined in Appendix 2 of the protocol
- •4. Subjects with ALT and/or AST = 3xULN
- •5. Subjects with bilirubin = 2xULN (with>35% direct bilirubin)
- •6. Subjects with severe renal impairment (estimated creatinine clearance <30
- •mL/min assessed within the previous 45 days) at the point of transition from
- •Study AMB115811
- •7. Subject has moderate - severe hepatic impairment (Child-Pugh class B-C with or
- •without cirrhosis) at the point of transition from study AMB115811
- •8. Subject with clinically significant fluid retention in the opinion of the investigator
- •9. Subject with clinically significant anemia in the opinion of the investigator
- •10. Subjects who are to enter another clinical trial or be treated with another
- •investigational product after exiting Study AMB115811.
- •Deviations from exclusion criteria are not allowed because they can potentially
- •jeopardize the scientific integrity of the study, regulatory acceptability or subject safety.
- •Therefore, adherence to the criteria as specified in the protocol is essential.
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