HYPERTENSIVE PATIENTS WITH DIABETIC AND NON DIABETIC CHRONIC NEPHROPATHY WITH AN ALBUMIN EXCRETION RATE >= 20 MG/GR CREATININE (20mg/24h) AND <= 1000 MG/GR CREATININE (1000mg/24h). MedDRA version: 6.1 Level: PT Classification code 10029151
Conditions
Interventions
Trade Name: Diovan® 80 mg
Product Name: Valsartan
Pharmaceutical Form: Tablet
INN or Proposed INN: valsartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Tr
Sponsors
Luis Miguel Ruilope Urioste
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 20mg/gr creatinine (20mg/24h) y 80 y 130 y =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect on urinary albumin excretion rate of 320 mg of Valsartan (with or without Hydrochlorothiazide) vs. 40 mg Lisinopril (with or without Hydrochlorothiazide) vs. the combination of 160mg Valsartan + 20 mg Lisinopril (with or without Hydrochlorothiazide) on hypertensive patients with chronic nephropathy, diabetic or non-diabetic, and albuminuria after 16 and 20 weeks of treatment. Both groups will be administered with a statin at the start of the wash-out period. ;Secondary Objective: To evaluate the effect on blood pressure control (pressure readings in doctor’s office) after 16 y 20 weeks of treatment. Both groups will be administered with a statin at the start of the wash-out period. To determine the effect on blood pressure control during 48-hours, after 16 and 20 weeks of treatment. Both groups will be administered with a statin at the start of the wash-out period. To evaluate the effect on blood pressure control at night and dipper/non dipper incidence after 20 weeks of treatment. To evaluate the effect on the left ventricular mass, using an electrocardiogram and Cornell´s and Sokolow´s criteria after 20 weeks of treatment. To evaluate the effect on renal function, means of creatinine clearance after 16 and 20 weeks of treatment. To evaluate the safety of the treatment after 20 weeks of treatment. ;Primary end point(s): Reduction percentage on urinary albumin excretion rate (median of three tests in early-morning orine collected in trhee days continuous), after 16 and 20 weeks of treatment. | — |
Countries
Spain
Outcome results
None listed