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

• Conditions: 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: 6.1Level: PTClassification code 10029151

• Registration Number: EUCTR2004-005044-27-ES
• Lead Sponsor: uis Miguel Ruilope Urioste

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 201

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 < 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

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 <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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified