EUCTR2008-001305-42-IT进行中（未招募）不适用
An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light meal - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 744
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
- •Male and female outpatients 65 years of age and older. 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). 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
- •Severe hypertension [Office msDBP ≥ 110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg]. History or evidence of a secondary form of hypertension. Known Keith-Wagener grade III or IV hypertensive retinopathy. History of hypertensive encephalopathy or cerebrovascular accident including a history of transient ischemic cerebral attack (TIA). Current diagnosis of heart failure (NYHA Class II-IV). History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). Current angina pectoris requiring pharmacological therapy other than nitrates. Second or third degree heart block without a pacemaker. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. Clinically significant valvular heart disease at the discretion of the principal investigator?s clinical judgment. History of Type 1 diabetes, or Type 2 diabetes and glycosylated hemoglobin (HbA1c) > 8 % at Visit 1. Serum potassium ≥ 5.5 mEq/L at Visit 1. Estimated glomerular filtration rate (GFR) < 45 mL/min/1.73 m2 using the MDRD formula at Visit 1. Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors or ARBs. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years. Previous participation in an investigational clinical trial within 1 month of Visit 1. Previous exposure to aliskiren within 3 months of Visit 1. 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). Women of child-bearing potential,PLEASE SEE PROTOCOL
研究者
相似试验
进行中（未招募）
不适用
An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light mealhypertensionEUCTR2008-001305-42-FRovartis Pharma Services AG744
进行中（未招募）
1 期
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 mealhypertensionEUCTR2008-001305-42-ISovartis Pharma Services AG744
进行中（未招募）
不适用
An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light mealhypertensionEUCTR2008-001305-42-SKovartis Pharma Services AG744
已完成
3 期
An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given a light mealincreased blood pressure10057166hypertensionNL-OMON31913ovartis124
进行中（未招募）
不适用
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 mealhypertensionEUCTR2008-001305-42-CZovartis Pharma Services AG744