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
- Conditions
- MedDRA version: 6.1Level: PTClassification code 10019315Prophylaxis 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.
- Registration Number
- EUCTR2004-001052-36-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method