NCT01453608已完成4 期
A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Vifor Pharma2 个研究点 分布在 2 个国家目标入组 304 人开始时间: 2011年10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
- 发起方
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Change in six minute walk test from baseline to week 24
研究概览
简要总结
The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.
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 (Participant, 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
- •Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
- •Reduced left ventricular ejection fraction
- •Capable of completing 6 minute walk test
- •At least 18 years of age and with written informed consent prior to any study specific procedures
排除标准
- •Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation
- •Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
- •Chronic liver disease and/or elevated liver enzymes
- •Vitamin B12 and/or serum folate deficiency
- •Subject is not using adequate contraceptive precautions during the study
- •Body weight ≤ 35 kg
- •No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures
研究组 & 干预措施
Ferinject (ferric carboxymaltose)
Experimental
干预措施: Ferinject (ferric carboxymaltose) (Drug)
Placebo (saline)
Placebo Comparator
干预措施: Placebo (saline) (Drug)
结局指标
主要结局
Change in six minute walk test from baseline to week 24
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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