Proteinuria MedDRA version: 9.1 Level: LLT Classification code 10037032 Term: Proteinuria
Conditions
Interventions
Trade Name: COZAAR 25, 50, and 100 mg tablets
Product Name: NA
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: losartan potassium
CAS Number: 124750-99-8
Other descriptive name: MK-0
Sponsors
MSD (Norge) AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is male or female from 1 to 17 years of age for the non-hypertensive strata or 6-17 years of age for the hypertensive strata; patient has a stable urine protein/creatinine ratio of >0.3 based upon the mean of three samples obtained during baseline. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is pregnant or nursing; patient has severe hypertension or significant coronary, neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease, or known history of uncorrected coarctation of the aorta, bilateral renal artery stenosis, or renal artery stenosis to a single kidney; major organ transplantation; steroid-responsive nephrotic-range proteinuria; clinically important lab abnormalities; significant rhythm disturbance; ACEI or ARB within 28 days; sensitivity to ACEI, ARB, or calcium channel blocker, or history of angioedema; requirement for cyclosporine or tacrolimus to treat renal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects of losartan compared to placebo (nonhypertensives) or amlodipine (hypertensives) on reduction of proteinuria in children and adolescents up to 17 years of age with hypertension (if >6 years old) and without hypertension (if >1 year old). To determine whether losartan is well tolerated at a dose of up to 1.4 mg/kg/day in pediatric patients with proteinuria.;Secondary Objective: To study the effect of losartan and amlodipine on blood pressure in pediatric patients with proteinuria and hypertension. To estimate the reduction from baseline in proteinuria for patients on losartan versus amlodipine (hypertensives). To estimate the reduction from baseline in proteinuria for patients on losartan versus placebo (non-hypertensives).;Primary end point(s): Reduction of proteinuria | — |
Countries
Germany, Hungary, Lithuania, Norway, Spain, United Kingdom
Outcome results
None listed