EUCTR2012-002677-53-FI进行中（未招募）不适用
Evaluation of the subcutaneous administration of 30 mg of S 78989 versus placebo and evaluation of the subcutaneous administration of 60 mg of S 78989 versus placebo on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation.A 28-weeks, randomised, double-blind, parallel-group, placebo controlled, international multicentre exploratory pilot study
Institut de Recherches Internationales Servier (I.R.I.S.)0 个研究点目标入组 90 人开始时间: 2012年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •- A mean maximum TBR (target to background ratio) > 1.8 centrally measured in any region of interest.
- •- No change in use of statin and other antidyslipidemic treatments since selection visit
- •- 50 years of age or older
- •- A documented recent (3-12 months, inclusive) acute coronary syndrome (ACS)
- •- Completion of all revascularisation procedures, 3 months before at least
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •- Positive HIV, Hepatitis C antibody and Hepatitis B antigen.
- •- Evidences of TB infection
- •- Type 1 diabetes and uncontrolled type 2 diabète
- •- Urinary incontinence
- •- Corrected QT interval duration (Bazett’s formula) > 450 ms for a male and 470 ms for a female measured at selection visit or Family history of long QT syndrome or congenital long QT syndrome.
- •- Chronic inflammatory disease
- •- History of malignancy within 3 years prior to Selection
- •- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- •- Infectious disease
- •- History or symptoms of a demyelinating disease
- •- History of coronary artery bypass graft
- •- Hemodynamic instability including hypotension, marked congestive heart failure.
- •- Severe or uncontrolled hypertension, or systolic blood pressure < 90 mmHg at selection.
- •- Introduction or modification of any anti-dyslipidemic drug treatment other than statin in
- •the two months prior to Selection
- •- Patient with any internal device or prosthesis.
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