A RANDOMIZED, DOUBLE BLIND, PARALLEL, CONTROLLED WITH PLACEBO OR AMLODIPINE, STUDY OF THE EFFECTS OF LOSARTAN IN THE PROTEINURY IN PEDIATRIC PATIENTS WITH OR WITHOUT HYPERTENSION.
- Conditions
- -I10 Essential (primary) hypertension-I15Essential (primary) hypertensionI10I15
- Registration Number
- PER-114-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient is male or female and is between 1 and 17 years old in the case of the non-hypertensive stratum or between 6 and 17 years old in the case of the hypertensive stratum. (The patient has not reached his 18th birthday at the time of randomization for any of the strata of the study).
• The patient can provide a reliable sample of the first morning urine preferably obtained from urination. Proper diaper collection is allowed.
• The patient has a documented history of proteinuria associated with a chronic kidney disease of any etiology.
• The patient has a stable urine protein-creatinine ratio of> 0.3 based on the average of three samples obtained during baseline.
• The patient has a glomerular filtration rate> 30 ml / min / 1.73m2, as determined by Schwartz´s formula, based on baseline serum creatinine
• Informed consent from parents is required. Patient assent will be obtained (when feasible) as required by local regulations.
• The patient is pregnant or breastfeeding (pregnancy tests will be performed on all patients 6 years of age and older at regular clinical visits during the study and extension).
• The patient has a history of severe or symptomatic hypertension (for example, seizures induced by hypertension, stroke, encephalopathy) within a period of 1 year prior to Visit 1. Patients requiring more than 2 drugs to control hypertension, or patients whose SiSBP or SiDBP> 99th percentile for their sex / age / height plus 5 mml-ig.
• The patient has a history of heart failure, hemodynamically significant obstructive valvular disease or cardiomyopathy.
• The patient has a clinically significant neurological, respiratory, gastrointestinal, hepatobiliary, or hematologic disease.
• The patient has a known history of coarctation of the uncorrected aorta, bilateral renal artery stenosis, or renal artery stenosis in a single kidney.
• The patient has a nephrotic protcinuria that responds to steroids.
• The patient has undergone a major organ transplant (for example, heart, kidney, liver).
• The patient has clinically significant laboratory values (as determined by the investigator) at Visit 1 outside the established normal range.
• The patient has a history of clinically significant rhythm disorders.
• The patient has received therapy with an AGE inhibitor (angiotensin converting enzyme), a diuretic or an angiotensin II receptor antagonist (ARB) within 28 days prior to randomization (Visit 4 / Day 1 Randomization). Antihypertensives (such as calcium channel blockers, beta blockers, diuretics, alpha blockers, centrally acting adrenergic agonists, other agents of the renin angiotensin aldosterone system, etc.) other than the study drugs cannot be administered during double blind phase of the study.
• The patient has a known sensitivity to losartan or another ARB, enalapril or other ACE-1, or a history of angioneurotic edema.
• The patient has a known sensitivity to amlodipine or another calcium channel blocker.
• The patient requires cyclosporine or tacrolimus to treat his kidney disease. Researchers may enter patients receiving other immunosuppressants, as long as the dose has been stable for a minimum of 2 months prior to Visit I. Patients receiving systemic corticosteroids may enter at the discretion of the investigator, provided the dose is has remained stable for a minimum of 2 months prior to Visit 1.
• The patient who, in the opinion of the investigator, will not cooperate fully, will not keep his appointments, or who has generally been unreliable.
• The patient has any other factor that limits their participation (for example, significant, concurrent, or life-threatening diseases, such as cancer or mental disability).
• The patient is currently participating or has participated in a study with a research compound within 30 days prior to Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method