WHO ICTRP trial
A prospective, open label, randomized, multicenter, multinational study…
EUCTR2005-001183-31-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2005-001183-31-ES |
|---|---|
| Public title | A prospective, open label, randomized, multicenter, multinational study evaluating the overall efficacy and safety including the effect on renal function of sirolimus (Rapamune?) replacing CNI in a standard care regimen of CNI, mycophenolate mofetil (MMF) and steroids in heart transplant patients |
| Scientific title | A prospective, open label, randomized, multicenter, multinational study evaluating the overall efficacy and safety including the effect on renal function of sirolimus (Rapamune?) replacing CNI in a standard care regimen of CNI, mycophenolate mofetil (MMF) and steroids in heart transplant patients |
| Primary sponsor | F. Hoffmann-La Roche Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes |
| Countries | Czech Republic;Belgium;Spain;Austria;United Kingdom |
| Conditions | Heart Transplant |
| Interventions | Trade Name: Rapamune Product Name: Rapamune Pharmaceutical Form: Coated tablet INN or Proposed INN: sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- |
| Registration date | Jun 9, 2005 |
| Target size | 650 |
| Secondary IDs | MT18328 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: