NCT00098007

A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients

Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in Addition to Certican and Steroids in de Novo Heart Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus (Certican)

Timeline

• Start date: 2004-08-09
• Primary completion: 2007-01-08
• Completion: 2007-01-08
• First posted: 2004-12-02
• Last updated: 2017-02-23

Locations

28 sites across 8 countries: United States, Australia, Austria, Brazil, Canada, Germany, Italy, Spain