EUCTR2004-000953-46-LT进行中（未招募）不适用
A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy andSafety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) in Magnetic ResonanceAngiography (MRA) of the Renal Arteries
Amersham plc0 个研究点目标入组 270 人开始时间: 2004年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1) The subject has a suspicion of or known renal artery stenosis.
- •(2) The subject has been referred to IA-DSA.
- •(3) The subject has had no intervention or a change in symptoms between 3D CE-MRA and IA-DSA.
- •(4) The subject is 18 years or older.
- •(5) The subject is conscious and able to comply with study procedures.
- •(6) Written and dated (i.e. date and time) informed consent is obtained.
- •(7) For women of childbearing potential, the results of a serum or urine human chorionic gonadotropin
- •(â-HCG) pregnancy test, done at screening (with the result known before investigational product
- •administration), must be negative. Only those women, who are surgically sterile (have had a
- •documented bilateral oophorectomy and/or documented hysterectomy) or postmenopausal (cessation
- •of menstruation for >1 year) will be allowed to enrol in the study without a pregnancy test at
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR
- •contrast media including, but not restricted to, the investigational product.
- •(2) The subject is lactating.
- •(3) The subject is pregnant as defined by a serum or urine â-HCG pregnancy test obtained within 24 hours
- •before investigational product administration.
- •(4) The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less
- •than 24 hours after the investigational product administration.
- •(5) The subject has received or is scheduled to receive X-ray contrast medium within less than 24 hours
- •prior to or less than 24 hours after administration of investigational product.
- •(6) The subject has received an investigational product within 30 days prior to or will receive an
- •investigational product less than 24 hours after investigational product administration.
- •(7) The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
- •(8) The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed
- •within 4 weeks prior to investigational product administration.
- •(9) The subject has a stent in the renal arteries.
- •(10) The subject has had a kidney transplantation.
- •(11) The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L).
- •(12) The subject has previously been included in this study.
- •(13) The subject has a contra-indication for MRI according to accepted clinical guidelines.
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