E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
- Stable Cardiovascular Disease and - Diabetes Mellitus Type 2 or Pre-diabetes |
- Enfermedad Cardiovascular estable y - Diabetes mellitus tipo 2 o Pre-diabetes |
|
E.1.1.1 | Medical condition in easily understood language |
- Stable Cardiovascular Disease and - Diabetes Mellitus Type 2 or Pre-diabetes |
- Enfermedad Cardiovascular estable y - Diabetes mellitus tipo 2 o Pre-diabetes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036481 |
E.1.2 | Term | Pre-diabetes |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
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 |
To determine whether the addition of aleglitazar versus placebo will reduce a composite outcome of CV death, non-fatal myocardial infarction or non-fatal stroke in patients with stable CVD and glucose abnormalities. |
Determinar si la adición de aleglitazar frente a placebo reducirá el criterio combinado de valoración que incluye las muertes de origen CV, casos de infarto de miocardio o ictus sin carácter mortal, en pacientes con enfermedad cardiovascular (EC) estable y alteraciones de la glucosa. |
|
E.2.2 | Secondary objectives of the trial |
To further explore the potential of aleglitazar to reduce CV morbidity, all-cause mortality and to delay the onset of T2D. |
Explorar la capacidad de aleglitazar para reducir la morbilidad CV y la mortalidad por cualquier causa, así como para retrasar la aparición de DT2. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Adult patients, >/= 40 years of age ? Prior Cardiovascular event, Coronary, Cerebrovascular or Perhipheral Arterial Disease ? Established Diabetes Mellitus Type 2 or Hba1c>/=5.7% |
- pacientes adultos >/= 40 años - anterior evento cardiovascular, coronario, cerebrovascular o enf. arterial periferica - Diabetes mellitus tipo 2 establecida o HbA1c >/=5.7% |
|
E.4 | Principal exclusion criteria |
? Concomitant treatment with a thiazolidinedione and/or fibrate ? Triglycerides >500 mg/dL ? Anaemia ? Estimated glomerular filtration rate <30mL/min/1.73m2 ? Symptomatic congestive heart failure classified as NYHA class II-IV ? Hospitalisation for congestive heart failure in last year |
- tratamiento concomitante con tiazolidindionas y/o fibratos - trigliceridos >500 mg/dl - anemia - tasa de filtración glomerular estimada <30mL/min/1,73m2 - Insuficiencia cardíaca congestiva sintomática clases II-IV de la clasificación de la NYHA - hospitalización por insuficiencia cardíaca congestiva en el último año |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to first occurrence of any component of the composite cardiovascular event of CV death, non-fatal MI ad non-fatal stroke |
Tiempo hasta que ocurra el primero de los componentes del evento cardiovascular combinado de muerte CV, IM no-mortal e ictus no-mortal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately 6 years |
Aproximadamente 6 años |
|
E.5.2 | Secondary end point(s) |
Time to first occurrence of any component of the composite all-cause mortality, non-fatal MI ad non-fatal stroke |
Tiempo hasta que ocurra el primero de los componentes del combinado muerte por cualquier causa, IM no-mortal e ictus no-mortal |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Approximately 6 years |
Aproximadamente 6 años |
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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) | 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.8.2 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 43 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 240 |
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 | No |
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 |
Argentina |
Australia |
Austria |
Belarus |
Brazil |
Canada |
Chile |
China |
Colombia |
Czech Republic |
Estonia |
Finland |
France |
Germany |
Hungary |
India |
Indonesia |
Israel |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Peru |
Philippines |
Poland |
Romania |
Russian Federation |
South Africa |
Spain |
Sweden |
Thailand |
Ukraine |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of the study is defined as the date of the last visit of the last patient to complete the study, or the date at which the last data point which is required for statistical analysis is received (prior to database closure), whichever is the later date. |
El fin del estudio se define como la fecha de la última visita del último paciente que complete el estudio, o la fecha en la que se obtenga el último dato requerido para el análisis estadístico (previamente al cierre de la base de datos), lo que acontezca mas tarde. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |