EUCTR2004-000745-37-ES进行中（未招募）1 期
ncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension
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
- 50
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
- •·Patients with PAH who have completed their participation in the preceding TRUST study with bosentan.
- •·Provide written informed consent.
- •·Female patients must be either postmenopausal or surgically or naturally sterile. Women of childbearing potential must have a negative pre-enrollment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.Reliable methods of contraception are:
- •Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- •Intra-uterine devices.
- •Oral, injectable or implantable contraceptives only in combination with a barrier method.
- •Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Eligible patients must meet none of the following exclusion criteria:
- •·Moderate to severe hepatic impairment i.e., Child-Pugh Class B or C
- •·Baseline liver aminotransferases, i.e., aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT), greater than 3 times the upper limit of normal ranges.
- •·Known hypersensitivity to bosentan or any of the excipients of the formulation.
- •·Treatment with glibenclamide, any calcineurin inhibitor.
- •·Pregnancy or breast-feeding
研究者
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ncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension)EUCTR2004-000745-37-ITACTELION PHARMACEUTICALS ITALIA
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ncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensioPulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisEUCTR2004-000745-37-GBActelion Pharmaceuticals Ltd.50
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