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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. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2004-001052-36-IT |
Date of registration:
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07/04/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A 12-month, multicenter, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican (1.5 mg/day starting dose) with reduced Neoral dose versus MMF with standard Neoral dose in de novo heart transplant recipients
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Scientific title:
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A 12-month, multicenter, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican (1.5 mg/day starting dose) with reduced Neoral dose versus MMF with standard Neoral dose in de novo heart transplant recipients |
Date of first enrolment:
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24/11/2004 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001052-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: 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) 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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Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic cardiac transplant. The drug should be used in combination with ciclosporin for microemulsion and corticosteroids. MedDRA version: 6.1
Level: PT
Classification code 10019315
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Intervention(s)
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Product Name: EVEROLIMUS Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .75-
Trade Name: CELLCEPT*50 CPR 500 MG Product Name: NA Product Code: NA Pharmaceutical Form: Tablet INN or Proposed INN: Mycophenolic acid CAS Number: 115007-34-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
Product Name: EVEROLIMUS Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 115007-34-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .5-
Product Name: EVEROLIMUS Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 115007-34-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25-
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Primary Outcome(s)
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Secondary Objective:
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Primary end point(s):
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Main Objective:
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Secondary ID(s)
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CRAD001A2411
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Source(s) of Monetary Support
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Results
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Results available:
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