Safety of once daily ivabradine compared to twice daily ivabradine

• Research type

  Research Study

• Full title

  Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease. A 6 to 12-month randomised double blind parallel groups multicentre study.

• IRAS ID

  110187

• Contact name

  HALL Alistair

• Sponsor organisation

  Servier Research & Development Ltd

• Eudract number

  2012-001668-31

• ISRCTN Number

  n/a

• Research summary

  The aim of this study is to compare the safety of a new once daily formulation of ivabradine with the currently available twice daily formulation. Ivabradine is approved for use in patients with coronary artery disease and who have angina. (Angina occurs when the heart muscle doesn't get sufficient oxygen, resulting in chest pain). Ivabradine inhibits a current in the pacemaker of the heart. This results in fewer heart beats per minute (bpm). Angina symptoms are thought to improved because the heart is working less and the arteries supplying the heart are now able to provide enough blood and oxygen. Due to the nature of coronary artery disease and angina, ivabradine is usually prescribed for long-term use. A once daily formulation is being developed to make it easier for patients to take. In addition, the new formulation has been designed to release drug more slowly and continuously over time, so there are steadier levels in the blood. This allows for the possibility of a steadier lower heart rate over 24 hours and also the potential for fewer side effects. In accordance with international guidelines a study comparing the safety of the existing drug with the new formulation over 6 months is required. In this study patients with stable coronary artery disease with or without angina will be given either the twice daily or the once daily formulation. Safety over 6 months will be compared by analysing reported adverse events in each group. Secondary aims include comparing efficacy, e.g. heart rate reduction and angina symptoms, and safety over 12 months and also the safety of switching between the 2 formulations. Patients will be enrolled at GP practices.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0397

• Date of REC Opinion

  12 Sep 2012

• REC opinion

  Favourable Opinion