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临床试验/NCT00376064
NCT00376064已完成4 期

A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)

研究概览

简要总结

This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

SMS995 + Carbegolin, Somavert + SMS995

Experimental

干预措施: Octreotide acetate and cabergoline/Octrotide and Somavert (Drug)

结局指标

主要结局

Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS)

时间窗: 8 months

次要结局

  • Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values(8 months)
  • Control clinical of symptoms of acromegaly(8 months)
  • Quality of Life assessment(8 months)
  • Safety and tolerability as assessed by frequency of AEs(8 months)
  • Effect of tumor size(8 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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