Ivabradine Drug Utilisation Study in Select European Countries: A Multinational, Retrospective, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

Study identification

• EU PAS number:
  EUPAS19522
• Study ID:
  26650
• Official title and acronym:
  Ivabradine Drug Utilisation Study in Select European Countries: A Multinational, Retrospective, Observational Study to Assess Effectiveness of Risk-Minimisation Measures
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This is a multinational retrospective drug utilization study aiming to assess how ivabradine is used in patients with chronic stable angina pectoris in routine clinical practice, and to evaluate the effectiveness of the new risk-minimisation measures (RMM) with a focus on whether the new contraindications (heart rate (HR) at treatment initiation lower than 70 bpm and concomitant use of verapamil or diltiazem) are followed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Solutions, PRA Real World Solutions

France

Germany

Study timelines

Date when funding contract was signed

Planned:10/06/2016

Actual:10/06/2016

Study start date

Planned:31/12/2016

Actual:14/07/2017

Data analysis start date

Planned:02/04/2018

Date of interim report, if expected

Planned:31/12/2017

Actual:12/12/2017

Date of final study report

Planned:30/06/2018

Actual:28/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Les Laboratoires Servier

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)