AusPAR: Ivabradine - Therapeutic Goods Administration

Safety
Studies providing evaluable safety data
AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3-3
Final 31 October 2012
Therapeutic Goods Administration
Pivotal efficacy study SHIFT Study (Study ID: CL3-16257-063)
In the pivotal efficacy study, safety measurements consisted of adverse events recording,
blood pressure measurements, ECG heart rate and standard laboratory tests taken
according to the assessment schedule below.
Table 12. Assessment schedule
• General adverse events (AEs) were assessed by open ended questioning at each study
visit.
• 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.
• Systolic and diastolic blood pressures were measured in sitting position after at least a
5 minute rest.
• 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.
Pivotal studies that assessed safety as a primary outcome
No studies were submitted that assessed safety as a primary outcome.
Dose response and non pivotal efficacy studies
Not applicable.
Other studies evaluable for safety only
Not applicable.
Page 36 of 101