The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation Patient Population-A Retrospective Database Analysis (Safety of Dabigatran vs. Warfarin in NVAF Patients)

Study identification

• EU PAS number:
  EUPAS10945
• Study ID:
  10946
• Official title and acronym:
  The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation Patient Population-A Retrospective Database Analysis (Safety of Dabigatran vs. Warfarin in NVAF Patients)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is an opportunity for Boehringer Ingelheim Pharmaceuticals Inc. to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.
• Study status:
  Finalised

Research institutions and networks

Institutions

Comprehensive Health Insights

Study timelines

Date when funding contract was signed

Planned:31/05/2013

Actual:31/05/2013

Study start date

Planned:22/01/2014

Actual:28/10/2014

Date of final study report

Planned:29/04/2016

Actual:09/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Pharmaceuticals, Inc

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

1160.192