EUCTR2008-001306-16-NL进行中（未招募）不适用
A 2 year extension to a 36-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
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. Patients that complete the CSPP100A2340 Core” study through Visit 10, while
- •on double-blind study drug.
- •2. Patients who are able to participate in the study, and who consent to do so after
- •the purpose and nature of the study has been clearly explained to them (written
- •informed consent).
- •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. NYHA class IV Congestive Heart Failure at Visit 1 (CSPP100A2340 ”Core” Study
- •Visit 10).
- •2. Symptomatic hypotension, or reported systolic BP < 90 mmHg within the 24 hours
- •prior to Visit 1 (CSPP100A2340 ”Core” Study Visit 10).
- •3. Known Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the
- •MDRD formula at Visit 1 (CSPP100A2340 Core” Study Visit 10).
- •4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state
- •of a female after conception and until the termination of gestation, confirmed by a
- •positive hCG laboratory test (> 5 mIU/ml).
- •5. Women of child-bearing potential (WOCBP), defined as all women physiologically
- •capable of becoming pregnant, including women whose career, lifestyle, or sexual
- •orientation precludes intercourse with a male partner and women whose
- •partners have been sterilized by vasectomy or other means, UNLESS they meet
- •the following definition of post-menopausal: 12 months of natural (spontaneous)
- •amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels
- •> 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without
- •hysterectomy OR are using one or more of the following acceptable methods of
- •contraception: surgical sterilization (e.g., bilateral or tubal ligation), hormonal
- •contraception (implantable, patch, oral), and double-barrier methods (any double
- •combination of: IUD, male or female condom with spermicidal gel, diaphragm,
- •sponge, cervical cap) if accepted by local ethics committees. Reliable
- •contraception should be maintained throughout the study and for at least 7 days
- •after study drug discontinuation.
- •6. Any surgical or medical condition that in the opinion of the investigator may place
- •the patient at higher risk from his/her participation in the study or is likely to
- •prevent the patient from complying with the requirements or completing the
研究者
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