PER-051-08已完成未知
A 36 week, multicenter, randomized, double-blind, placebo- controlled, parallel-group, pilot study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-AMI patients when added to optimized standard therapy
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2008年8月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
入选标准
- •Pacientes masculinos o femeninos de 18 o mas años de edad.
- •Pacientes dentro de 7-42 dias de un infarto agudo de miocardio asociado con disfuncion sistolica ventricular izquierda previo a la Visita 1
- •Disfuncion sistolica ventricular izquierda documentada asociada con la calificacion obtenida de infarto agudo de miocardio por evaluacion clinica (estudio) despues de infarto del miocardio previo a Visita 1.
- •Los pacientes deberan estar en dosis estables, de las siguientes medicaciones concomitantes estandares de cuidado post infarto por al menos 2 semanas antes de la Visita 1 a menos que este contraindicado debido a intolerancia
- •Un paciente debe estar en una dosis estable basada en la evidencia de un inhibidor de la enzima convertidora de angiotensina (ACEI) o un bloqueador del receptor de angiotensina (ARB) pero no ambos, por al menos 2 semanas previas a la Visita 1, a menos de que este contraindicado debido a intolerancia. Para pacientes sin una dosis basada en una evidencia de un ACEI o ARB, la razon (Ej. paciente intolerante a estas medicaciones) debe ser documentada.
- •Pacientes que sean elegibles para participar en el estudio, y que consientan en hacerlo despues de haberseles explicado claramente el proposito y la naturaleza de la investigacion (consentimiento informado escrito)
排除标准
- •Patients who require a combination therapy of both: ACEI and ARB at Visit 1 or at any time during the study.
- •Hypertrophic cardiomyopathies due to other etiologies other than hypertension (eg, idiopathic or valvular).
- •Severe refractory hypertension defined as MSSBP> 180 mmHg and / or MSDBP> 110 mmhg) at Visit 2.
- •Stenotic lesions or hemodynamically significant valvular, subvalvular or supravalvular obstructive lesions.
- •Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infectious cardiomyopathy (eg, Chagas disease).
- •Cardiogenic shock or systolic BP <100 mmhg or diastolic <60 mmHg within 24 hours before Visit 1 or Visit 2.
- •Estimated glomerular filtration rate (eGFR) <30 ml / min / 1.73m2 using the MDRD formula in Visit 1.
- •Cerebrovascular accident or transient ischemic event (TIA) within 6 months of Visit 1 of the study.
- •Serum potassium> 5.1 mEq / L, or dehydration in Visit 1 of the study.
- •Significant cardiovascular valvular disease that is expected to lead to cardiac surgery during the course of the study.
- •Unstable angina that requires intervention between Visit 1 and Visit 2.
- •Any coronary artery bypass procedure within 7 days prior to Visit 1.
- •CABG, PCI, CRT, LVAD or heart transplant planned or anticipated after the patient is enrolled in the study.
- •Current abuse or recent history of abuse of alcohol or other drugs in the past 12 months).
- •Significant non-cardiovascular disease or similar condition that results in death before completing the study, eg transplantation of a major organ (life expectancy <1 year).
- •Any medical or surgical condition that may significantly alter the absorption, distribution, metabolism or excretion of study drugs
- •Any medical or surgical condition that in the opinion of the investigator may place the patient at increased risk for participation in the study or is likely to prevent the patient from meeting the study requirements or completing the study.
- •History of non-compliance with medical regimens or lack of desire to comply with the study protocol.
- •Any condition that in the opinion of the investigator or the Novartis monitor may threaten the evaluation of efficacy or safety.
- •People directly involved in the execution of this protocol.
- •Use of other investigational drugs within 30 days or 5 half-lives before Visit 1, whichever is longer.
- •Known or suspected contraindications, or history of hypersensitivity to any of the study drugs or drugs belonging to the same therapeutic drug (eg, renin inhibitors) as the study drug.
- •History of malignancy of any organic system, treated or untreated, within the past 5 years or when there is evidence of local recurrence or metastasis, with the exception of localized basal cell carcinoma of the skin.
- •Pregnant or lactating women, where pregnancy is defined as a state of the woman after conception until the end of pregnancy, confirmed by a positive laboratory test of hCG (> 5 mlU / ml).
- •Woman with potential to procreate (WOCBP), defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation prevents their relationship with a male partner and women whose partners have been sterilized by vasectomy or other means unless they meet the following definition of postmenopause: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea
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