A Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in addition to Certican 61668; and Steroids in de novo Heart Transplant Recipients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000541-38-IT

Enrollment

200

Registered

2005-09-20

Start date

2004-09-27

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. It should be used in combination with ciclosporin for microemulsion and corticosteroids. MedDRA version: 6.1 Level: PT Classification code 10056409

Interventions

Product Name: EVEROLIMUS Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Current Sponsor code: RAD001 Concentration unit: mg milligram(s) Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: ;Secondary Objective: ;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026