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临床试验/NCT00652418
NCT00652418已完成2 期

Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities

Bayer0 个研究点目标入组 12 人开始时间: 2004年7月最近更新:
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
Bayer
入组人数
12
主要终点
Diagnostic ability

研究概览

简要总结

The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.

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
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography

排除标准

  • Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
  • Patients with allergy to contrast media
  • Patients with serious hepatic impairment
  • Patients with serious renal impairment

研究组 & 干预措施

Arm 1

Active Comparator

干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) (Drug)

Arm 2

Experimental

干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) (Drug)

结局指标

主要结局

Diagnostic ability

时间窗: MRI image in blinded read

次要结局

  • Visibility(MRI image in blinded read)
  • Diagnostic confidence(MRI image in blinded read)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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