An 8 week double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren administered alone and in combination with hydrochlorothiazide in patiens with essential hypertension

ovartis Sverige AB0 个研究点目标入组 2,685 人开始时间: 2004年6月29日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 2,685

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

•Patients with essential hypertension. Patients must have a MSDBP =90 mmHg and<100 mmHg at the visit prior to Visit 3 (Visit 2 or optional Visit 201), and a MSDBP =95 mmHg and <110 mmHg at Visit 3 (day 1).
•Patients must have an absolute difference of =10 mmHg in their average sitting diastolic blood pressure during the last two visits (Visit 2 and 3 or the optional visit 201 and 3) of the single-blind lead-in period of the study.
•Outpatients 18 years of age and older
•Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
•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 have 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

•Patients previously treated with aliskiren
•Severe hypertension (grade 3 WHO classification; MSDBP =110 mmHg and/or 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
•Transient ischemic cerebral attack during the 12 months prior to Visit 1.
•Current diagnosis of heart failure (NYHA Class II-IV)
•History of myocardial infarction, coronary bypass surgery, or any percutaneaous coronary intervention (PCI) during the 12 months prior to Visit 1.
•Current angina pectoris requiring pharmacological therapy (other than sublingual nitroglycerin).
•Second or third degree heart block without a pacemaker.
•Concurrently potentially life threatening arrhythmia or symptomatic arrhythmia.
•Clinically significant valvular heart disease.
•Type 1 or Type 2 diabetes mellitus with poor glycemic control defined as fasting glycosylated hemoglobin (HbA1c) >9% at Visit 1.
•Serum sodium and/or serum potassium less than the lower limit of normal, dehydration, or hyperkalemia =5.5 mEq/L at Visit 1.
•Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
•History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
•Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1.
•Currently active gastritits, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
•Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
•Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 2 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
•Evidence of renal impairment as determined by any one of the following: serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
•History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
•History or evidence of drug or alcohol abuse within the last 12 months.
•Pregnant or nursing women.
•Any surgical or medical condition, which 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 of the study or completing the study.
•Known or suspected contraindications to the study medications, including history of allergy to thiazide diuretics or other sulfonamide derived drugs.
•History of gouty arthritis.

研究者

发起方

ovartis Sverige AB

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