Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial. SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends. SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking. When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study. Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor. The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.
Study Type
OBSERVATIONAL
Enrollment
3,439
The study is non-interventional with no study-specific treatment during the study and the patients will be treated as per Treating Physician's and patient's own discretion.
Master Centre for USA
Plainsboro, New Jersey, United States
Master Centre for Algeria
Algiers, Algeria
Master Centre for Argentina
Prov. de Buenos Aires, Argentina
Master Centre for Australia
North Sydney, New South Wales, Australia
Cárdio Pulmonar da Bahia
Salvador, Estado de Bahia, Brazil
Time to all-cause death
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of non-fatal myocardial infarction
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of non-fatal stroke
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to diagnosis of type 2 diabetes
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of any type of cancer
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of a composite of obesity related cancer defined by WHO
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of knee replacement
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of bariatric surgery
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of anti-obesity medical treatment
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Time to first occurrence of use of continuous positive airways pressure (CPAP) device
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Total number of myocardial infarctions
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Total number of strokes
Measured in months
Time frame: From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
Measured in Kg
Time frame: From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Change in Patient reported quality of life questionnaire (EQ-5D-5L) from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
EQ-5D-5L score The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale \[VAS\]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.
Time frame: From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10)
Days
Time frame: From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
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Hospital do Coração do Brasil
Brasília, Federal District, Brazil
Eurolatino Medical Research Center
Uberlândia, Minas Gerais, Brazil
Núcleo de Pesquisa Clínica S/S
Curitiba, Paraná, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
AngioCor Blumenau
Blumenau, Santa Catarina, Brazil
...and 28 more locations