EUCTR2005-000286-19-DK进行中（未招募）不适用
A randomized, double-blind, cross-over, 4-period, 4 treatment, within-subject placebo-controlled study to assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt nephropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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/or female patients from 30-80 years of age.
- •2.Type 2 diabetes (defined using WHO criteria)
- •3.Incipient or overt nephropathy (urinary albumin excretion =100 but = 2000 mg/day). Investigator should make an effort to have two subgroups (incipient and overt nephropathy) as balanced as possible, but at least 6 patients in each subgroup.
- •4.GFR =40ml per minute (either documented in the 4 months prior to the screening visit or assessed at randomization [Day -1, Period 1])
- •5.To be eligible for randomization, patients must fulfill the following criteria:
- •a) Patients on ongoing hypertensive therapy must have a blood pressure = 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (Run-in period)
- •b) Newly diagnosed hypertensive patients must have a blood pressure = 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1)
- •6.Female patients must be postmenopausal (i.e. must have had no regular menstrual bleeding for at least 2 years prior to inclusion) or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening. Menopause will be confirmed by a plasma 17ß-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L. Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor
- •7.Oral body temperature within the range 35.0-37.5 °C
- •8.Able to provide written informed consent prior to study participation.
- •Subject information and consent forms generated by the investigator must be approved by the sponsor prior to submission to the Ethics Committee (EC)/Institutional Review Board (IRB). A copy of the subject information and consent forms approved by the EC/IRB must be forwarded to the sponsor prior to study initiation.
- •9.Able to communicate well with the investigator and comply with the requirements of the study.
- •10.Patients must be willing and medically able to discontinue anti-hypertensive treatment or any other medication which is prohibited in the study protocol.
- •11.Patients must be on stable hypoglycemic medications for at least 8 weeks prior to visit 1 (Screening visit)
- •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
- •Subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:
- •1.Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- •2.Severe Hypertension Grade 3 WHO classification (MSDBP =110 mmHg and/or MSSBP =180 mmHg)
- •3.ASA treatment >1g/day or regular use of NSAIDs
- •4.Kidney disease not caused by diabetes or hypertension
- •5.Serum potassium < 3.5 or > 5.1 mEq/L
- •6.GFR < 40 ml/min/1.73m2 as measured by the MDRD formula
- •7.Serum albumin < 2.0mg/dL
- •8.Hypertensive encephalopathy at any time prior to Visit 1.
- •Cerebrovascular accident at any time in the last 12 motnts prior to Visit 1
- •9.Transient ischemic cerebral attack during the 6 months prior to Visit 1
- •10.Current diagnosis of heart failure (NYHA Class II-IV)
- •11.History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
- •12.Second or third degree heart block without a pacemaker
- •13.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- •14.Clinically significant valvular heart disease
- •15.Type 1 diabetes mellitus
- •16.Uncontrolled Type II diabetes mellitus (HbA1C >11 %)
- •17.History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
- •18.Pregnant or nursing women
- •19.Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •20.Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •21.Significant illness within the two weeks prior to dosing.
- •22.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/AST or SGPT/ALT values exceeding 2 x ULN at Visit 1, and Gamma GT x 3 ULN at Visit 1 a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •Current treatment with cholestyramine or cholestipol resins
- •23.History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- •24.History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •25.History of drug or alcohol abuse within the 12 months prior to dosing.
- •26.Persons directly involved in the execution of this protocol.
- •27.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety
- •28.History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- •29.Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
- •30.Any surgical or medica
研究者
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