E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019314 |
E.1.2 | Term | Heart transplant |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The major aim of this extension study was to evaluate the long-term (i.e. 5 to 7 years) effect of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE main study (Protocol: CRAD001ANO02, EudraCT no.: 2009-013074-41).
|
|
E.2.2 | Secondary objectives of the trial |
Quality of life will be examined using three validated questionnaires, i.e. the SF-36, EQ 5D, and the BDI form. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit,
• Patients who, and are coming for a regularan annual clinic visit 5 or to 7 years after randomization in the main study
• Obtaining of a will be asked to participate in this 5 to 7-year follow-up examination. A separate signed patient informed consent will be required for participation in this follow-up examination.
|
|
E.4 | Principal exclusion criteria |
Patients with a retransplanted heart since the original SCHEDULE study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Renal function as assessed by measured GFR (mGFR)
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
5-7 years after completion of the main study. |
|
E.5.2 | Secondary end point(s) |
Secondary endpoints:
• Progression of CAV by IVUS analysis
• Myocardial structure and function by echocardiography assessment
• Quality of life by SF-36 (Minnesota Living with Heart Failure Questionnaire), Euro Quality of Life 5D (EQ 5D), and Beck Depression Inventory (BDI) form
• Number of adverse events (AEs)/serious adverse events (SAEs)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
5-7 years after completion of the main study. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
This is a follow up after the SCHEDULE study. SCHEDULE was an open, randomised and controlled study. |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |