Cardiovascular Safety Study of 0.1 and 0.3 mmol/kg Magnevist® Injection at Two Injection Rates (Bolus and 10 mL/15 Sec.) in Normal Subjects Following a Randomized, Cross-over Design Using Placebo and a Concurrent Positive Control
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 71
- 主要终点
- The primary study variable was heart-rate corrected QT (QTc) interval
研究概览
简要总结
The purpose of this study is to determine what effect Magnevist (gadopentetate dimeglumine) injection has on the way the heart conducts the electrical impulses that allow it to beat effectively. The study will compare Magnevist injection's effect to that of placebo (a saline injection).
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects with an electrocardiogram [ECG] (normal sinus rhythm [SR], QTc > 450 msec) without clinically significant abnormalities
- •Non-smoker
排除标准
- •History of cardiovascular disease- Pregnant or nursing- Had any contraindication to moxifloxacin
研究组 & 干预措施
Arm 4
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
Arm 1
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
Arm 2
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
Arm 3
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
Arm 5
干预措施: Moxifloxacin (BAY12-8039) (Drug)
Arm 6
干预措施: Placebo (Drug)
结局指标
主要结局
The primary study variable was heart-rate corrected QT (QTc) interval
时间窗: Within 15 min postinjection
次要结局
- Adverse event monitoring, laboratory evaluations(24 hrs postinjection)
- ECG variables and overall interpretation(24 hrs postinjection)