SELECT follow-up study to evaluate Long-term Impact oF anti-obEsity medication(EX9536-4750)

JRCT ID: jRCT1031230250

Registered date:21/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: subjects with established CV disease and overweight or obesity
• Date of first enrollment: 01/09/2023
• Target sample size: 110
• Countries of recruitment: Algeria,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Colombia,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Latvia,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Death, Myocardial infarction, Stroke, Type 2 diabetes diagnosis, Concomitant medication, Body weight, Cancer and its location, Treatment for overweight or obesity, Surgery for knee replacement, Hospitalisation, Quality of life (EQ-5D-5L), Sleep apnoea

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable

Include criteria

1. Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
2. Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

• Exclude criteria: Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Related Information

• Primary Sponsor: Okada Takumi