An eight-week double-blind, multi-center, randomized,placebo-controlled, parallel-group study to evaluate theefficacy and safety of aliskiren 75mg, 150mg and 300mg inelderly patients with essential hypertension when givenwith a light meal

ovartis Pharma Services AG0 个研究点目标入组 744 人开始时间: 2008年5月5日最近更新: 2016年10月17日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma Services AG
入组人数: 744

研究概览入排标准研究者记录与标识符相似试验

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. Male and female outpatients 65 years of age and older.
•2. Patients who are eligible and able to participate in the study, and who consent to do so
•after the purpose and nature of the investigation has been clearly explained to them
•(written informed consent).
•3. At the randomization Visit patients must have an office msSBP greater than or equal to
•150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15
•mmHg difference during the last two visits of the single blind run-in period
•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. Severe hypertension [Office msDBP =110 mmHg and/or mean sitting systolic blood
•pressure (msSBP) = 180 mmHg].
•2. History or evidence of a secondary form of hypertension.
•3. Known Keith-Wagener grade III or IV hypertensive retinopathy.
•4. History of hypertensive encephalopathy or cerebrovascular accident, including a history of
•transient ischemic cerebral attack (TIA).
•5. Current diagnosis of heart failure (NYHA Class II-IV).
•6. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary
•intervention (PCI).
•7. Current angina pectoris requiring pharmacological therapy other than nitrates.
•8. Second or third degree heart block without a pacemaker.
•9. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
•10. Clinically significant valvular heart disease at the discretion of the principal investigator’s
•clinical judgment.
•11. History of Type 1 diabetes, or Type 2 diabetes and glycosylated hemoglobin (HbA1c)
•> 8% at Visit 1.
•12. Serum potassium = 5.5 mEq/L at Visit 1.
•13. Estimated glomerular filtration rate (GFR) < 45 mL/min/1.73 m2 using the MDRD
•formula at Visit 1.
•14. Known or suspected contraindications to the study medications, including history of
•allergy to ACE-Inhibitors or ARBs.
•15. Any surgical or medical condition which might significantly alter the absorption,
•distribution, metabolism, or excretion of study drugs.
•16. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer)
•within the past five years.
•17. Previous participation in an investigational clinical trial within 1 month of Visit 1
•18. Previous exposure to aliskiren within 3 months of Visit 1
•19. 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).
•20. Women of child-bearing potential, defined as all women physiologically capable of
•becoming pregnant. UNLESS they are:
•women whose career, lifestyle, or sexual orientation precludes intercourse with a male
•women whose partners have been sterilized by vasectomy or other means
•using a highly effective method of birth control (i.e. one that results in a less than 1%
•per year failure rate when used consistently and correctly, such as implants,
•injectables, combined oral contraceptives, and some intrauterine devices (IUDs),
•Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods)
•are not acceptable Reliable contraception should be maintained throughout the study
•and for 14 days after study drug discontinuation.
•Woman are considered post-menopausal and not of child bearing potential if they have had 12
•months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age
•appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with
•serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without
•hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the
•reproductive status of the woman has been confirmed by follow up hormone level assessment.
•Additional exclusion criteria for patients in ambulatory blood pressure measurement substudy:
•21. Upper arm circumference > 42 cm.
•22. Third shift or night workers.

研究者

发起方

ovartis Pharma Services AG

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