EUCTR2004-002849-12-IT进行中（未招募）不适用
Extension to a multicentre, randomized, crossover, open labeldose finding study to compare the safety, efficacy and PK/PD relationship of multiple doses of SOM230 (200, 400 and 600 mcg b.i.d.) and doses of open label of Sandostatin (100 mcg t.i.d.)in acromegalic patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •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
- 未提供
研究者
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Extension to a multicenter, randomized, crossover, open label, dose finding study to compare the safety, efficacy and PK/PD relationship of multiple doses of SOM230 (200, 400 and 600 µg b.i.d.) and doses of open label Sandostatin (100 µg t.i.d.) in acromegalic patientsAcromegaly is a rare, serious condition characterized by chronic hypersecretion of GH (growth hormone) caused in over 95% of patients by a GH-secreting pituitary adenoma. Clinical manifestations are due to excess GH and elevated IGF-I concentrations and/or the central pressure effects of the tumor mass. Clinical features comprise structural and functional changes occurring in practically all organs. Cardiovascular disease is the main reason for morbidity and increased mortality of patients.MedDRA version: 7.0Level: LLTClassification code 10000599EUCTR2004-002849-12-GBovartis Pharmaceuticals UK Ltd48
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Extension to a multicenter, randomized, crossover, open label, dose finding study to compare the safety, efficacy and PK/PD relationship of multiple doses of SOM230 (200, 400 and 600 µg b.i.d.) and doses of open label Sandostatin (100 µg t.i.d.) in acromegalic patientsAcromegaly is a rare, serious condition characterized by chronic hypersecretion of GH (growth hormone) caused in over 95% of patients by a GH-secreting pituitary adenoma. Clinical manifestations are due to excess GH and elevated IGF-I concentrations and/or the central pressure effects of the tumor mass. Clinical features comprise structural and functional changes occurring in practically all organs. Cardiovascular disease is the main reason for morbidity and increased mortality of patients.MedDRA version: 7.0Level: LLTClassification code 10000599EUCTR2004-002849-12-ESovartis Farmaceutica S.A.48
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