EUCTR2008-001306-16-IT进行中（未招募）不适用
Extension 1 to Protocol 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 - ND
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
- •Inclusion criteria 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
- •Exclusion criteria 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 study.
研究者
相似试验
已完成
3 期
Extension 1 to Protocol 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 therapyheart attackMyocardial infarct10028593NL-OMON32303ovartis30
进行中（未招募）
1 期
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 therapyEssential HypertensionEUCTR2008-001306-16-BEovartis Pharma Services AG800
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 therapyEssential HypertensionMedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertensionEUCTR2008-001306-16-HUovartis Pharma Services AG800
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 therapyEssential HypertensionEUCTR2008-001306-16-NLovartis Pharma Services AG800
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 therapyEssential HypertensionEUCTR2008-001306-16-CZovartis Pharma Services AG800