EUCTR2004-002252-33-ES进行中（未招募）不适用
A twelve-week, randomized, double-blind, parallel-group, multicenter, dose escalation study to evaluate the efficacy and safety of aliskiren administered alone and in combination with atenolol in patients with essential hypertension - non aplicable
ovartis Farmacéutica S.A0 个研究点目标入组 672 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 672
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
- •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 with essential hypertension.
- •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).
- •To be eligible for randomization into the double-blind treatment period at Visit 3, patients must also fulfill the following criteria:
- •Patients must have a MSDBP ? 90 mmHg and < 110 mmHg at 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 in their MSDBP = 10 mmHg during the last two visits (Visit 2 and 3 or the optional visit 201 and 3) 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.Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
- •2.Severe hypertension (MSDBP = 110 mmHg and/or MSSBP = 180 mmHg)
- •3.History or evidence of a secondary form of hypertension
- •4.Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •5.History of hypertensive encephalopathy or cerebrovascular accident
- •6.Transient ischemic cerebral attack during the 12 months prior to Visit 1.
- •7.Current diagnosis of heart failure (NYHA Class II-IV).
- •8.History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1.
- •9.Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates)
- •10.Second or third degree heart block without a pacemaker.
- •11.Sinus bradycardia (heart rate less than 55 bpm).
- •12.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- •13.History of sick sinus syndrome.
- •14.Clinically significant valvular heart disease.
- •15.Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9% at Visit 1.
- •16.History of bronchospasm, asthma or chronic obstructive pulmonary disease.
- •17.Symptomatic peripheral artery disease.
- •18.Serum sodium less than the lower limit of normal, serum potassium <3.5 mEq/L or = 5.5 mEq/L, or dehydration at Visit 1.
- •19.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 gastritis, 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 3 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 times the upper limit of normal at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
- •Current treatment with cholestyramine and colestipol resins.
- •20.History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
- •21.History or evidence of drug or alcohol abuse within the last 12 months.
- •22.Pregnant or nursing women.
- •23.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.
- •24.Known or suspected contraindications to the study medications including history of allergy to atenolol or other ß-blockers.
- •25.History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •26.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
- •27.Participation
研究者
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