NCT00464776已完成1 期
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 Diabetic Patients With Incipient or Overt Nephropathy
适应症
干预措施
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
- 26
- 试验地点
- 1
- 主要终点
- Investigate the antiproteinuric effect of increasing doses of Aliskiren compared to matching placebo.
研究概览
简要总结
This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 patients from 30-80 years of age.
- •Type 2 diabetes (defined using World Health Organization criteria)
- •Incipient or overt nephropathy (urinary albumin excretion 100 but ≤ 2000 mg/day).
- •Glomerular filtration rate (GFR) 40ml per minute
- •To be eligible for randomization, patients must fulfill the following criteria:
- •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)
- •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)
- •Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening
- •Oral body temperature within the range 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.
- •Patients must be willing and medically able to discontinue anti-hypertensive treatment or any other medication which is prohibited in the study protocol.
- •Patients must be on stable hypoglycemic medications for at least 8 weeks prior to visit 1 (Screening visit).
排除标准
- •Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- •Severe Hypertension Grade 3 WHO classification Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
- •Acetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal 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 < 2.0mg/dL
- •History of hypertensive encephalopathy or cerebrovascular accident at any time 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
- •Pregnant or nursing women
- •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 portocaval shunt
- •Current treatment with cholestyramine or cholestipol resins
- •History of immunocompromise, including a positive HIV 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
- •Patients who previously participated in any Aliskiren study.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Various sequences of 3 doses of Aliskiren plus placebo
干预措施: Aliskiren (Drug)
2
Experimental
Various sequences of 3 doses of Aliskiren plus placebo
干预措施: Aliskiren (Drug)
3
Experimental
Various sequences of 3 doses of Aliskiren plus placebo
干预措施: Aliskiren (Drug)
4
Experimental
Various sequences of 3 doses of Aliskiren plus placebo
干预措施: Aliskiren (Drug)
结局指标
主要结局
Investigate the antiproteinuric effect of increasing doses of Aliskiren compared to matching placebo.
时间窗: End of study
次要结局
- Assess the effect on Glomerular Filtration Rate (GFR) of multiple dose administration of Aliskiren.(End of study)
- Assess the effect on blood pressure of multiple dose administration of Aliskiren.(End of study)
- To investigate whether there is a change in biomarkers of inflammation and cardiovascular risk.(End of study)
研究者
研究点 (1)
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