NCT01260636已完成3 期
A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diagnostic Preference
研究概览
简要总结
To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries
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
- •18 yrs of age or older
- •referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
- •Able to provide written informed consent and comply with protocol requirements
- •Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol
排除标准
- •pregnant or lactating females
- •Known allergy to one or more of the ingredients in the products under investigation
- •Significant congestive heart failure ( Class IV)
- •Moderate to severe chronic kidney disease
- •Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
- •Vascular stents in vessels of interest
- •Received another contrast agent in the 24 hrs preceding or proceeding each exam
- •Previously entered into the study
- •Contraindications to MRI
- •Severe Claustrophobia Undergone DSA between the two exams
研究组 & 干预措施
MultiHance contrast agent
Experimental
MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)
干预措施: Gadobenate Dimeglumine (Drug)
Magnevist
Active Comparator
Magnevist administered at a dose of 0.2 mmol/kg
干预措施: Gadopentetate Dimeglumine (Drug)
结局指标
主要结局
Diagnostic Preference
时间窗: Immediately post dose
Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference
次要结局
- Safety comparison of two diagnostic agents(UP to 24 hours post dose of each contrast agent)
研究者
研究点 (1)
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