E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
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 |
Evaluar la seguridad y tolerabilidad a largo plazo de vildagliptina 50 mg qd o placebo en pacientes con DMT2 e insuficiencia renal moderada o grave durante 52 semanas de tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
Objetivo(s) exploratorio(s) Investigar la eficacia a largo plazo de vildagliptina 50 mg qd o placebo en pacientes con DMT2 e insuficiencia renal moderada o grave evaluando la reducción de la hemoglobina A1c (HbA1c) y de la glucosa plasmática en ayunas (GPA) respecto a la basal después de 52 semanas de tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
La información sobre los criterios de inclusión y exclusión del protocolo principal se encuentran en el protocolo principal.
1.Consentimiento informado por escrito para participar en el estudio de extensión. 2.Capacidad para cumplir con todos los requisitos del estudio. |
|
E.4 | Principal exclusion criteria |
1.Retirada prematura del estudio principal. 2.Condiciones médicas concomitantes que interfieran la interpretación de los resultados del estudio como las que se definen en el protocolo principal. 3.No cumplimiento del protocolo de estudio principal según el criterio del investigador. 4.Pacientes potencialmente poco fiables; y aquellos que según el criterio del investigador no son adecuados para el estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Las variables de los objetivos principales incluyen tratamiento de los acontecimientos adversos aparecidos (incluyendo acontecimiento de hipoglucemia y acontecimientos de especial interés) y acontecimientos adversos graves. También se evaluarán los resultados de las pruebas de laboratorio de bioquímica y hematología, los hallazgos en el ECG y las constantes vitales/peso corporal. |
|
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
multi center, double-dummy |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 61 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |