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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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12 June 2012 |
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Main ID: |
EUCTR2006-006415-74-HU |
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Date of registration:
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19/03/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension - Proteinuria in Pediatric Patients
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Scientific title:
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A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension - Proteinuria in Pediatric Patients |
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Date of first enrolment:
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31/05/2007 |
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Target sample size:
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300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006415-74 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Germany
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Hungary
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Lithuania
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Norway
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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:
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Proteinuria
MedDRA version: 9.1
Level: LLT
Classification code 10037032
Term: Proteinuria
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Intervention(s)
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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-0954
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25,50,100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Losartan Potassium Oral Suspension
Product Code: MK-0954 Oral Suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: losartan potassium
CAS Number: 124750-99-8
Other descriptive name: MK-0954
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Trade Name: ISTIN
Product Name: NA
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: Amlodipine Besilate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Amlodipine Besilate Oral Suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: amlodipine besilate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral use
Trade Name: INNOVACE
Product Name: NA
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: enalapril maleate
Current Sponsor code: MK-0421
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5,5,10,20-
Product Name: Enalapril Maleate Oral Suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: enalapril maleate
Current Sponsor code: Mk-0421
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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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).
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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.
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Primary end point(s): Reduction of proteinuria
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Secondary ID(s)
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0954-326
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2006-006415-74-NO
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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