EUCTR2012-001646-18-AT进行中（未招募）不适用
A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH)
GlaxoSmithKline Research & Developement Ltd0 个研究点目标入组 160 人开始时间: 2013年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Demographics
- •1. Subject must be between 18 and 75 years of age, inclusive, at the Screening Visit
- •CTEPH Diagnosis and Classification
- •2. Subjects must have a diagnosis of CTEPH at an expert centre* with a positive V/Q and CT angiogram and a pulmonary angiogram if available within 3 months prior to screening
- •*Expert centre is an expert multidisciplinary team which must include at least one cardiology or respiratory consultant, and one consultant PEA surgeon
- •3. Subject must meet all of the following haemodynamic criteria by means of a RHC within 4 weeks prior to screening:
- •i. mPAP of >25 mmHg
- •ii. PVR > 400 dynes.sec/cm5
- •iii. PCWP or LVEDP of <15 mmHg
- •4. Subjects must have previously been judged inoperable due to the obstruction being surgically inaccessible (i.e. distal disease) by an expert multidisciplinary team which must include at least one cardiology or respiratory consultant, and one consultant PEA surgeon. For countries with CTEPH expert centers (including at least a surgeon with sound experience performing PEAs) the expert team will be the local expert
- •centre. For countries without a CTEPH surgical expert center a central adjudication committee will assess the operability of the subjects during the screening period. See Section 6.1.1 of the protocol.
- •5. Subject must walk a distance of =150m and =475m at the screening visit. See Section 6.2.1.
- •6. Subject must have a current diagnosis of being in WHO Functional Class II or III.
- •7. Subject, with or without supplemental oxygen, must have a resting arterial oxygen saturation (SaO2) =>92% as measured by pulse oximetry at the Screening Visit.
- •8. Subjects must have received anticoagulation for a minimum of 3 months prior to Screening.
- •9. 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 1 of the protocol.
- •10. Subject must agree not to participate in a clinical study involving another investigational drug or device throughout this study.
- •11. 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 investigational product that may impact subject eligibility is provided in the IB and product label.
- •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.
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •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
- •CTEPH Treatments
- •1. Subject received previous PAH therapy (PDE5i, ERA, chronic prostanoid use*) within 12 weeks prior to the screening visit
- •*Chronic prostanoid use is considered >7 days of treatment
- •2. Subject has previously discontinued other ERA in either another clinical study or commercial product for safety or tolerability reasons other than for liver function abnormalities.
- •3. Subject has a known hypersensitivity to the Investigational Products, the metabolites, or formulation excipients.
- •Other Therapies
- •4. Subject has previously undergone a pulmonary endartorectamy.
- •5. Subject receiving intravenous inotropes within 2 weeks prior to the Screening Visit (e.g. dopamine, dobutamine)
- •6. Subjects receiving Calcium Channel Blockers or HMG-CoA reductase inhibitors (i.e., statins) on an unstable dose 4 weeks prior to the Screening Visit (to be eligible subjects must not have changed their dose <4 weeks prior to the screening visit)
- •Exercise Programmes
- •7. Subject has not enrolled in an exercise training program for cardiopulmonary rehabilitation within 12 weeks prior to the Screening Visit and must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 16 weeks of the study. Subjects enrolled in an exercise program for pulmonary rehabilitation 12 weeks prior to screening may enter the study if they agree to maintain their current level of rehabilitation for the first 16 weeks of the study.
- •Laboratory Values at Screening
- •8. ALT and/or AST = 3xULN
- •9. Bilirubin = 1.5xULN (>35% direct bilirubin)
- •10. Subject has severe renal impairment (estimated creatinine clearance <30 mL/min) at the Screening Visit
- •NOTE: if serum bilirubin is elevated at screening it will need to be fractionated to exclude liver injury and determine if the patient is able to be included in the trial.
- •11. Subject has moderate - severe hepatic impairment (Child-Pugh class B-C with or without cirrhosis) at the Screening Visit
- •Haematology and bleeding disorders
- •12. Subject has clinically significant anaemia: Hb < 10g/dL
- •13. Subjects with bleeding disorders or significant active peptic ulceration in the opinion of the investigator
- •Cardiovascular
- •14. Subject has uncontrolled hypertension (>180/110 mmHg) at screening
- •15. Subject has severe hypotension (<90/50 mmHg) at screening
- •16. Subject has had an acute myocardial infarction within the last 90 days prior to screening
- •17. Subject has, in the opinion of the investigator, clinically significant aortic or mitral valve disease; pericardial constriction; restrictive or congestive cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction (ejection fraction <50% of normal); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic
- •hypotension; fluid depletion.
- •General Medical Conditions
- •18. Subject with significant pulmonary disease (FEV1<70% of predicted): COPD, Emphysema, evidence of fibrotic lung disease on imaging
- •19. Subject has clinically significant fluid retention in the opinion of the investigator
- •20. Subject with significant obesity (BMI = 35), cardiovascular, musculoskeletal or any other condition that in the opinion of the investigator may involve an impairment of exercise capacity or the performance of the 6MWD test (e.g. previous history of hip/knee surgery, lower limb ulcers associated with autoimmune diseases)
- •21. Subject with cardiovascular, liver, renal, haematologic, gastro
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