EUCTR2004-004391-36-CZ进行中（未招募）不适用
A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
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
- Male
入选标准
- •1. Male patients age 18-65 years,
- •2. Bosentan-naïve,
- •3. WHO functional class III/IV, in need of TRACLEER,
- •4. Patients with iPAH or PAH secondary to CHD,
- •5. Written informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2.Patients with PAH secondary to connective tissue vascular diseases or HIV,
- •3.Patients who have undergone a vasectomy,
- •4.Patients with a sperm concentration < 20 x 10[6]/mL at the first or second baseline visit,
- •5.Patients with average baseline sperm motility <20% or normal sperm morphology <5%,
- •6.Body weight < 50 kg,
- •7.Hypotension, defined as systolic blood pressure less than 85 mm Hg,
- •8.AST and/or ALT plasma levels greater than 3 times ULN,
- •9.Hypersensitivity to bosentan or any of the components of the formulation,
- •10.Treatment with glyburide, calcineurin inhibitors (e.g., cyclosporine A, tacrolimus) or fluconazole at inclusion or planned during the study,
- •11.Treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study,
- •12.Current treatment less than 3 months prior to inclusion or planned new treatment with prostacylin or prostacyclin analogues (e.g., Flolan or Remodulin),
- •13.Patients receiving spironolactone (aldactone) less than 3 months prior to inclusion or dose >25 mg/day at baseline or anytime during the study,
- •14.Patients who received an investigational drug in the month preceding the study start or who are due to be treated with another investigational drug during the study period,
- •15.Known drug or alcohol dependence or any other factors that will interfere with conduct of the study,
- •16.Any illness other than PAH that will reduce life expectancy to less than 6 months,
- •17.Active cancer,
- •18.Prior treatment with an anti-neoplastic agent or ionizing radiation,
- •19.Hot tub/Jacuzzi use,
- •20.Uncontrolled diseases including diabetes, liver or kidney disease.
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