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 |
Malattia cardiovascolare stabile e diabete mellito di tipo 2 o pre-diabete |
|
E.1.1.1 | Medical condition in easily understood language |
- Stable Cardiovascular Disease and - Diabetes Mellitus Type 2 or Pre-diabetes |
Malattia cardiovascolare stabile e diabete mellito di tipo 2 o pre-diabete |
|
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 | 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 | 100000004861 |
|
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. |
Determinare se l’aggiunta di aleglitazar rispetto al placebo riduca un esito composito di morte cardiovascolare (CV), infarto miocardico non fatale o ictus non fatale in pazienti con malattia cardiovascolare stabile (CVD) e anomalie del glucosio |
|
E.2.2 | Secondary objectives of the trial |
To further explore the potential of aleglitazar to reduce CV morbidity, allcause mortality and to delay the onset of T2D. |
Esplorare ulteriormente il potenziale di aleglitazar per ridurre la morbilità CV, la mortalità per tutte le cause e ritardare l’insorgenza di diabete di tipo 2 (T2D). |
|
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% |
. pazienti adulti di età >/= 40 anni
. storia di pregresso evento CV, coronaropatia, malattia cerebrovascolare o malattia arteriosa periferica
. diabete mellito di tipo 2 confermato 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 |
1.Attuale trattamento con un TZD o fibrato; 2.Trigliceridi (a digiuno) > 500 mg/dl; 3. Anemia; 4.eGFR (MDRD) <30 mL/min/1,73 m2; 5.Insufficienza cardiaca congestizia sintomatica classificata come NYHA classe II-IV; 6.Ospedalizzazione per una diagnosi primaria d’insufficienza cardiaca nel periodo di 12 mesi precedenti la randomizzazione |
|
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 |
Time to first occurrence of any component of the composite cardiovascular event of CV death, non-fatal MI ad non-fatal stroke |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately 6 years |
Circa 6 anni |
|
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 |
Time to first occurrence of any component of the composite all-cause mortality, non-fatal MI ad non-fatal stroke |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Approximately 6 years |
Circa 6 anni |
|
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 |
Tollerabilità |
|
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 | 20 |
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 |
Belarus |
Brazil |
Canada |
Chile |
China |
Colombia |
India |
Indonesia |
Israel |
Korea, Republic of |
Malaysia |
Mexico |
Peru |
Philippines |
Russian Federation |
South Africa |
Thailand |
Ukraine |
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 |
La fine dello studio è definita come la data dell’ultima visita dell’ultimo paziente per completare lo studio o la data in cui viene ricevuto l’ultimo punto dati, richiesto per l’analisi statistica (prima della chiusura del database). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 69 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 69 |
E.8.9.2 | In all countries concerned by the trial days | 0 |