Studies providing evaluable safety data

Safety

Studies providing evaluable safety data

Pivotal efficacy study SHIFT Study (Study ID: CL3-16257-063)

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  General adverse events (AEs) were assessed by open ended questioning at each study visit.
  
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  Blood samples were drawn for standard laboratory tests at the selection visit (or just before the inclusion visit) and at the M004, M012, M024, M036, M048 and TERM visits in a fasting state. The blood samples obtained at selection were to be analysed for haematology, clinical chemistry (sodium, potassium, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT)) fasting plasma glucose, total and low density lipoprotein (LDL) cholesterol.
  
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  Systolic and diastolic blood pressures were measured in sitting position after at least a 5 minute rest.
  
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  A standard 12-lead ECG was performed after at least a 5 minute rest. The heart rate was measured and relevant findings including cardiac rhythm were recorded at each visit. Significant ECG abnormalities were to be reported as adverse events.