EUCTR2009-012196-10-NL进行中（未招募）不适用
A single-blind, double dummy, randomized, multi-dose, two sequence, crossover, study to investigate the Added effects of Renin Inhibitor (aliskiren 300 mg) on Albuminuria in non-diabetic nephropathy patients treated with ramipril 10 mg and Volume intervention (ARIA)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
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 female outpatients 18 to 70 years (inclusive) of age included.
- •2. Non-diabetic renal disease as established by history, urine analysis, serum biochemistry tests and/or renal biopsy with residual albuminuria by UAER of >300 mg/24 hrs from 24 hour urine collection during conventional RAAS-blockade of at least 8 weeks of ACE-inhibition or ARB treatment at the maximum recommended dose.
- •3. Glomerular Filtration Rate (GFR) >30 ml/min/1.73m2 as determined by creatinine clearance
- •4. Patients with a history of hypertension and msSBP of =160 mm Hg and msDBP =105 mm Hg at screening and baseline.
- •5. Female subjects of child bearing potential must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), for at least three (3) months prior to first dosing and for the entire duration of the study, through study completion and for 30 days following study completion.
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to screening. Menopause will be confirmed by a FSH level determined by the reference range used by the local clinical laboratory at screening.
- •Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to screening. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
- •6. Patient must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
- •7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the 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
- •1. Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
- •2. Renovascular hypertension or severe hypertension (msDBP >105 mmHg and msSBP >160 mmHg)
- •3. Pregnant or nursing (lactating) women, where pregnancy is defined as a state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
- •4. A medical history of instable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
- •5. Diabetes mellitus (Type 1 and Type 2)
- •6. Heart failure NYHA class III-IV
- •7. High rate of renal function loss (decline in creatinine clearance >6 ml/min/1.73m2 during the previous year or 1.5 ml/min/1.73m2 per month)
- •8. If subject is currently using and expected to continue or start any medication listed in Section 6.6.5 concomitant medication.
- •9. Albuminuria >3 g/24h and/ or hypoalbuminaemia <28 g/L
- •10. Serum potassium >5.3 mmol/L
- •For the full list of exclusion criteria, please refer to the protocol.
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