NCT00042432已完成2 期
A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 54
- 主要终点
- Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
研究概览
简要总结
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients must have chronic renal insufficiency (pre-dialysis)
- •Have below normal creatinine clearance
- •Have elevated parathyroid hormone levels
排除标准
- •Pregnant or nursing
- •Heart attack in the last 3 months.
研究组 & 干预措施
cinacalcet (AMG 073)
Experimental
干预措施: cinacalcet (AMG 073) (Drug)
Placebo
Placebo Comparator
干预措施: cinacalcet (AMG 073) (Drug)
结局指标
主要结局
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
时间窗: Efficacy assessment phase (weeks 12-18)
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
次要结局
- Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase(Baseline, efficacy assessment phase (weeks 12-18))
研究者
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