ACTRN12606000289516尚未招募4 期
Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH)
Actelion Phrmaceuticals Australia0 个研究点目标入组 15 人开始时间: 2006年7月7日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Symptomatic (modified New York Heart Associate (NYHA) class III) iPAH or PAH-SScPAH confirmed by right heart catheterisation performed within 3 months before enrolment, mean pulmonary artery pressure (mPAP) > 25mmHg, pulmonary capillary wedge pressure (PCWP) < 15 mmHg and PVR > 3 mmHg/l/minWomen of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for 3 months after study treatment termination.Bosentan naïve patientsSigned written informed consent
排除标准
- •PAH other than iPAH or PAH-SScSignificant vasoreactivity during right heart catheterization defined as a fall in mPAP to < 40 mmHg with a decrease = 10 mmHg and with a normal cardiac index (= 2.5 l/min.m2)Severe obstructive lung disease: Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Vapacity (FVC) < 0.5Severe restrictive lung disease: Total Lung Capacity (TLC) < 0.7 of normal predicted valueHemoglobin <75% of the lower limit of the normal rangeSystolic blood pressure < 85 mmHgBody weight < 40 kgPregnancy or breast-feedingModerate to severe hepatic impairment, i.e., Child-Pugh Class B or C.Baseline aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 times the upper limit of the normal (ULN) range.Treatment for iPAH or PAH-SSc within 1 month before start of study treatment, excluding warfarin and acute administration of vasodilators for vascular reactivity testing during heart catheterization.Treatment with epoprostenol or other prostacyclin analogs for iPAH or PAH-SSc within 1 month before start of study treatmentTreatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.Current treatment with cyclosporine A or tacrolimusHypersensitivity to bosentan or any of the excipients of its formulation.Patient who received an investigational drug (such as sildenafil) within 3 months before start of study treatmentConditions that prevent compliance with the protocol or adherence to therapy.
研究者
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