EUCTR2010-019547-19-NL进行中（未招募）1 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.
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
- 41
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. Male or female at least 8 years of age and not yet 18 years of age at the time of randomization.
- •2. A current diagnosis of PAH (WHO Group 1) with WHO class II or III symptoms in one of the following categories:
- •Idiopathic
- •Heritable [familial]
- •Secondary to connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease (CTD), systemic lupus erythematosus, or overlap syndrome).
- •Persistent PAH despite surgical repair (at least 6 months prior to the screening visit) of atrial septal defects, ventricular septal defects, atrio-ventricular septal defects, and persistent patent ductus.
- •3. Have met the following hemodynamic criteria for subjects with right heart catheterization (RHC) when performed as part of the diagnosis or routine care:
- •mean pulmonary arterial pressure (mPAP) of ?25 mmHg
- •pulmonary vascular resistance (PVR) of ?240 dyne?sec/cm5
- •left ventricular end diastolic pressure (LEVDP) or pulmonary capillary wedge pressure (PCWP) of =15 mmHg.
- •4. Subjects must either be treatment naïve, have discontinued treatment with another ERA (e.g., bosentan) at least 1 month previously because of elevated liver function tests (LFTs), or have been on a stable dose of background treatment for PAH (e.g., sildenafil or prostacyclin) for at least one month prior to the Screening Visit. Background treatment for PAH, if any, should not change from the Screening Visit until the end of all Treatment Period assessments.
- •5. Subjects who discontinued ERA treatment due to elevated LFTs, must have LFTs of <3 x Upper Limit of Normal (ULN).
- •6. 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 at the Screening and Baseline/Randomisation Visits and agrees 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 study drug (reliable methods of contraception are listed in Appendix 2.
- •7. 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
- •1. Subjects currently taking an ERA.
- •2. Subjects currently taking cyclosporine A.
- •3. Subjects whose body weight is less than 20 Kg.
- •4. Subjects who have not tolerated PAH therapy due to adverse effects which may be related to their mechanism of action (e.g., prostanoids, ERA, PDE-5 inhibitors) with the exception of liver abnormalities for those subjects who were receiving another ERA.
- •5. Female subjects who are pregnant or breastfeeding.
- •6. Subjects with diagnosis of active hepatitis (hepatitis B surface antibody and hepatitis C antibody), or clinically significant hepatic enzyme elevation (i.e., ALT, AST or AP >3xULN) at Screening.
- •7. Subjects with severe renal impairment (creatinine clearance <30 mL/min) at Screening.
- •8. Subject has clinically significant fluid retention in the opinion of the investigator.
- •9. Subject has clinically significant anaemia in the opinion of the investigator.
- •10. Subject has a known hypersensitivity to the study drug, the metabolites, or formulation excipients.
- •11. Subjects who have participated in another trial or have taken another investigational product during the previous 30 days.
- •12. Alcohol abuse, illicit drug use within 1 year.
- •13. Any concurrent condition or concurrent use of medication that would affect subject safety in the opinion of the investigator.
研究者
相似试验
进行中（未招募）
不适用
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.Pulmonary Arterial HypertensionEUCTR2010-019547-19-GRGlaxoSmithKline Research & Development, Ltd66
进行中（未招募）
1 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.Pulmonary Arterial HypertensionMedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-019547-19-DEGlaxoSmithKline Research & Development, Ltd41
进行中（未招募）
1 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.Pulmonary Arterial HypertensionMedDRA version: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertensionMedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionMedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionMedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionMedDRA version: 12.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionEUCTR2010-019547-19-HUGlaxoSmithKline Research & Development, Ltd41
进行中（未招募）
1 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.Pulmonary Arterial HypertensionMedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertensionMedDRA version: 12.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertensionMedDRA version: 12.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertensionMedDRA version: 12.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertensionMedDRA version: 12.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertensionEUCTR2010-019547-19-FRGlaxoSmithKline Research & Development, Ltd41
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)Pulmonary Arterial HypertensionPulmonary10037454HypertensionNL-OMON34214GlaxoSmithKline5