A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis

Abbott32 个研究点分布在 1 个国家目标入组 78 人开始时间: 2004年8月最近更新: 2011年1月19日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Abbott
入组人数: 78
试验地点: 32
主要终点: The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme.

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: Double

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

未提供

排除标准

未提供

结局指标

主要结局

The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels

次要结局

未报告次要终点

研究者

发起方

Abbott

申办方类型

Industry

研究点 (32)

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