NCT00068042已完成4 期
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 56
- 主要终点
- Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
研究概览
简要总结
The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of acromegaly
- •IGF-I levels >=1.3xULN (upper limit of normal) at screening
- •No history of radiotherapy or prior treatment with other drugs for acromegaly
- •Minimum of two months must have elapsed post surgery prior to screening
排除标准
- •Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
- •AST/ALT >= 3xULN (upper limit of normal)
- •Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
- •Visual field defects (except post surgical stable residual defects)
- •Unable to self administer drug
结局指标
主要结局
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
次要结局
- The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
研究者
研究点 (56)
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