NCT00936988已完成2 期
A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (Cinacalcet) in Primary Hyperparathyroidism
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
- 45
- 主要终点
- Nature, frequency, severity, and relationship to treatment of adverse events
研究概览
简要总结
This multicenter, open-label, single-arm, extension study was designed to evaluate long-term tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after they completed the parent study, 990120. All subjects began treatment with 30 mg cinacalcet twice daily (BID), with dose adjustments made per protocol-specified guidelines. The study consisted of 2 consecutive phases that occurred in the following order: a dose-titration phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.
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
- 否
入选标准
- •Successfully completed the parent study 990120
- •Agreed to use highly effective (in the opinion of the principal investigator) contraceptive measures throughout the study
- •Were able to comprehend and were willing to give written informed consent for participation in the study
排除标准
- •Pregnant or breast-feeding
- •Had a psychiatric disorder that interfered with the understanding and giving of informed consent or compliance with protocol requirements
- •Had any other condition that reduced the chance of obtaining data (eg, known poor compliance)
- •Participating in another investigational study at the time of study entry
- •Had any unstable medical condition, defined as having been hospitalized within 28 days before day 1, or otherwise unstable in the judgment of the investigator
研究组 & 干预措施
cinacalcet
Experimental
干预措施: cinacalcet (Drug)
结局指标
主要结局
Nature, frequency, severity, and relationship to treatment of adverse events
时间窗: 234 weeks
次要结局
- Calcium levels and plasma iPTH during the maintenance phase(234 weeks)
- Percentage changes in BMD from baseline of the parent study to each measurement time point and absolute BMD values, as assessed by DXA scans of proximal femur, lumbar spine (L1-L4), forearm, and total body scans(234 weeks)
研究者
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