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Main
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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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24 July 2012 |
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Main ID: |
EUCTR2005-003885-40-IT |
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Date of registration:
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15/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Scientific title:
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ACE-inhibitors and Angiotensin two receptor antagonists in IgA nephropathy with mild proteinuria -
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Date of first enrolment:
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18/10/2005 |
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Target sample size:
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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:2005-003885-40 |
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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:
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: terapia di supporto
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? yes
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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The primary aim of the study consists in testing the hypothesis that blockade of the RAS may decrease the risk of developing adverse effects in patients with benign IgAN.Such blockade would first achieved with unique pharmacological class then shifting to the association of the two classes as soon as ineffective blockade is documented
MedDRA version: 9.1
Level: SOC
Classification code 10038359
Term: Renal and urinary disorders
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Intervention(s)
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Product Name: Ramipril
Pharmaceutical Form: Tablet
INN or Proposed INN: Ramipril
CAS Number: 87333-19-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Irbesartan
Pharmaceutical Form: Tablet
INN or Proposed INN: Irbesartan
CAS Number: 138402-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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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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