NCT00595049已完成4 期
Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).
Actelion1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2006年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.
研究概览
简要总结
The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc).
The second purpose is to investigate if bosentan affects the enlargement of small vessels in the lungs in response to natural chemicals in patients with iPAH and PAH-SSc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •· Men or women >18 years of age.·
- •Symptomatic (modified NYHA class III) iPAH or PAH-SSc·
- •PAH confirmed by right heart catheterization performed within 3 months before enrolment mPAP > 25 mmHg, PCWP < 15 mmHg and PVR > 3 mmHg/l/min.
- •Women 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 patients
排除标准
- •· PAH other than iPAH or PAH-SSc
- •Significant 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: FEV1/FVC < 0.5
- •Severe restrictive lung disease: TLC < 0.7 of normal predicted value
- •Hemoglobin <75% of the lower limit of the normal range· Systolic blood pressure < 85 mmHg
- •Body weight < 40 kg
- •Pregnancy or breast-feeding
- •Moderate 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 treatment
- •Treatment with glibenclamide (glyburide), fluconazole ketoconazole or ritonavir within 1 week before start of study treatment.
- •Current treatment with cyclosporine A or tacrolimus
- •Hypersensitivity 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 treatment
- •Conditions that prevent compliance with the protocol or adherence to therapy.
研究组 & 干预措施
bosentan
Experimental
干预措施: bosentan (Drug)
结局指标
主要结局
Change from baseline (BL) to 6 mths in the IVUS-derived measurement of pulmonary artery wall thickness.
时间窗: Baseline to 6 months
Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to actylcholine (Ach).
时间窗: Baseline to 6 months
次要结局
- Change from BL to 6 mths in each of the IVUS derived pulmonary artery parameters.(Baseline to 6 months)
- Change from BL to 6 mths in pulmonary microvascular circulation dilator responses to sodium nitroprusside.(Baseline to 6 months)
- Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the PMVC dilator responses versus changes in 6MWD.(Baseline to 6 months)
- Correlation between the change from BL to 6 mths of each of the IVUS-derived parameters and the pulmonary microvascular circulation (PMVC) dilator responses versus changes in PVR.(Baseline to 6 months)
研究者
研究点 (1)
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