EUCTR2004-005044-27-ES进行中（未招募）不适用
COMPARATIVE, RANDOMIZED, OPEN, MULTICENTER TRIAL ASSESING THE EFFECT ON ALBUMIN EXCRETION RATE OF 320 MG. VALSARTAN (WITH OR WITHOUT HYDROCHLOROTHIAZIDE) vs. 40 MG. LISINOPRIL (WITH OR WITHOUT HYDROCHLOROTHIAZIDE) vs. tHE COMBINATION OF 160 MG VALSARTAN + 20 MG LISINOPRIL (WITH OR WITHOUT HYDROCHLOROTHIAZIDE), ON HYPERTENSIVE PATIENTS WITH DIABETIC AND NON DIABETIC CHRONIC NEPHROPATHY AND ALBUMINURIA
uis Miguel Ruilope Urioste0 个研究点目标入组 201 人开始时间: 2006年1月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
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
- •Males or females aged between 18 and 75 years, they both included.
- •Women of childbearing potential (i.e., not surgically sterile or less than one year post-menopausal) must have a negative gonadotrophin pregnancy test (urine or serum) immediately prior to entry in the study and must use adequate contraception (for women on oral contraceptives, additional barrier contraception must be used) both during and for a month after the end of treatment.
- •Patients with Chronic Nephropathy of diabetic or non-diabetic etiology established by the data recorded in the clinical history, the serum clinical chemistry and/or urinalysis, defined by the presence of at least one of the following criteria:
- •a) Serum creatinine concentration > 132 µmol/l (1.3 mg/dl) in males or >123 µmol/l (1.2mg/dl) in females and < 265 µmol/l (3mg/dl).)
- •b) Calculated glomerular filtration rate of 30-90 ml/min/ 1.73 m2
- •Patients with urinary albumin excretion rate > 20mg/gr creatinine (20mg/24h) y < 1000mg/gr creatinine (1000mg/24h) on baseline and/or that meet micro or macroalbuminuria criteria (WHO: Microalbuminuria: 20-299 mg/gr creatinine; Macroalbuminuria: 300-1000 mg/gr creatinine), on laboratory data performed 6 months before to be selected for the study.
- •Hypertensive patients, with or without treatment, whose mean diastolic blood pressure > 80 y < 110 mmHg and/or systolic blood pressure > 130 y <180 mmHg
- •Written informed consent from the subject or his/her legally acceptable representative, if the subject is not competent to give 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
- •Patients with age lower than 18 and higher than 75 years.
- •Pregnant women, nursing mothers or women of childbearing potential not practising adequate means of contraception.
- •Known or suspected hypersensitivity to any therapeutic agents included in the study.
- •Patients with urinary albumin excretion rate <20mg/gr. creatinine (20mg/24h) and > 1000mg/gr. creatinine (1000mg/24h).
- •Patients with nephrotic syndrome.
- •Patients who need a substitutive renal therapy.
- •Patients who need treatment due to refractory edema.
- •Patients needing treatment with corticosteroids, non-steroideal anti-inflammatories, or any other drugs that could affect patients` blood pressure.
- •Patients with normal cholesterol total levels (< 135 mg/dl) or patients who needn't statin treatment.
- •Patients in treatment with a statin whose chage by simvastatin 20 mg/day could mean an incovenience in investigator´s judgement.
- •Serum creatinine concentration < 132 µmol/l (1.3 mg/dl) in males or < 123 µmol/l (1.2mg/dl) in females and > 265 µmol/l (3mg/dl).
- •Hypertension malignant (retinopathy grade III-IV/IV).
- •Secondary Hypertension (unilateral or bilateral renal artery stenosis, coarctation of the aorta, pheocromocytoma).
- •Patients with hypertensive encephalopathy, acute myocardial infarction, transitory ischemic accident or cerebrovascular accident in the last year and/or chronic cardiac insufficiency or serious peripheral arteriopathy.
- •Patients with a history of hepatic, gastrointestinal, hematological, pulmonary or neurological disease, clinically significant.
- •Any other medical situation that in investigator’s judgement could interfere with patient’s participation in the study or provoke any significant risk for patient.
- •Alcoholism, drug addiction, psychiatric disorder or other factors that in investigator’s judgement could complicate patient’s participation in the study.
- •Patients who took Angiotensin-converting enzyme inhibitors or Angiotensin-II Receptor Antagonists within one month prior to the study randomization.
- •Patients with sifnificant cardiac arrythmias (atrial fibrilation) that could interfere with ambulatory blood pressure monitoring results
- •Patients who work at night including hours from 0:00 to 4:00 and who are used to sleeping in the morning.
- •Participation in any other studies within 30 days prior to the study entry or planned participation in any other studies simultaneously.
- •Patients who did not give the informed consent to participate in the study.
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