NCT00464880已完成1 期
A Randomized, Double-Blind, Parallel-Group, Cross-Over, 4-Period, 4 Treatment, Within-Subject Placebo-Controlled Study to Assess the Reno-Protective Effect of Renin Inhibition With Aliskiren as an Alternative to Irbesartan in Type 2 Patients With Incipient/Overt Diabetic Nephropathy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To investigate whether renin-inhibition using aliskiren 300 mg daily could be a treatment alternative to the angiotensin II receptor antagonist irbesartan 300 mg with an equivalent potential for reno-protection
研究概览
简要总结
This study will assess the reno-protective effect of renin inhibition with aliskiren as an alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic nephropathy.
详细描述
Antiproteinuric Effects of Aliskiren (Renin Inhibitor), Irbesartan (Angiotensin Receptor Antagonist) and the Combination in Hypertensive Patients With Type 2 Diabetes and Incipient/Overt Diabetic Nephropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female subjects between the ages of 30-80 years with a diagnosis of type 2 diabetes (World Health Organization criteria)
- •Body mass index (BMI) within the range of 20 and
- •Incipient or overt diabetic nephropathy (urinary albumin excretion ≥ 100 but ≤ 2000 mg/day).
- •Glomerular filtration rate (GFR) ≥ 40 ml/min documented in the last 4 months prior to randomization
- •To be eligible for randomization, patients must fulfill the following criteria:
- •Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (run-in period).
- •Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mmHg but lower than 170/105 mmHg at Visit 2 (Day -1).
- •Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 (Day -1).
- •Patients must be willing and medically able to discontinue all angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
- •Female patients must be postmenopausal, have had a bilateral oophorectomy, or have been surgically sterilized or hysterectomized at least 6 months prior to screening.
- •Oral body temperature within the range of 35.0-37.5 °C
- •Able to provide written informed consent prior to study participation.
- •Able to communicate well with the investigator and comply with the requirements of the study.
排除标准
- •Severe hypertension, Grade 3 World Health Organization (WHO) classification (mean sitting diastolic blood pressure [MSDBP] ≥ 110 mmHg and/or mean sitting systolic blood pressure [MSSBP] ≤ 180 mmHg)
- •Acetylsalicylic acid (ASA) treatment > 1 g/day or regular use of nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Kidney disease not caused by diabetes or hypertension
- •Serum potassium < 3.5 or > 5.1 mEq/L
- •GFR < 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula
- •Serum albumin < 2.0 mg/dL
- •History of hypertensive encephalopathy or cerebrovascular accident in the last 12 months prior to Visit 1
- •Transient ischemic cerebral attack during the 6 months prior to Visit 1
- •Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV)
- •History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
- •Second or third degree heart block without a pacemaker
- •Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- •Clinically significant valvular heart disease
- •Type 1 diabetes mellitus
- •Uncontrolled type II diabetes mellitus; hemoglobin subtype A1C (HbA1C) > 11%
- •History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
- •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •Significant illness within the two weeks prior to dosing.
- •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
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- •Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portacaval shunt
- •Current treatment with cholestyramine or colestipol resins
- •History of immunocompromise, including a positive test result.
- •History of a positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
- •History of drug or alcohol abuse within the 12 months prior to dosing.
- •Persons directly involved in the execution of this protocol.
- •Any condition that, in the opinion of the investigator or the Novartis medical monitor, would jeopardize the evaluation of efficacy or safety
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- •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
- •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
- •Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- •Patients who previously participated in any aliskiren study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To investigate whether renin-inhibition using aliskiren 300 mg daily could be a treatment alternative to the angiotensin II receptor antagonist irbesartan 300 mg with an equivalent potential for reno-protection
次要结局
- To investigate whether combination therapy using aliskiren 300 mg daily and irbesartan 300 mg daily has a greater effect on reno-protection than either drug alone
- To investigate whether aliskiren, irbesartan or the combination reduce biomarkers of inflammation and cardiovascular risk
研究者
研究点 (2)
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