A Study of Treatments for Overactive Bladder: Incidence and Validation of Cardiovascular and Cancer Outcomes and Examination of Drug-Use Patterns in a US Health Care Claims Data Environment (OAB)

Study identification

• EU PAS number:
  EUPAS7924
• Study ID:
  29827
• Official title and acronym:
  A Study of Treatments for Overactive Bladder: Incidence and Validation of Cardiovascular and Cancer Outcomes and Examination of Drug-Use Patterns in a US Health Care Claims Data Environment (OAB)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study estimating the incidence rates of cardiovascular and cancer outcomes among initiators of currently available antimuscarinic drugs (oxybutynin, tolterodine, darifenacin, solifenacin, trospium, or fesoterodine) from 01 January 2004 through 30 September 2012. The study calculated incidence rates of the following endpoints : - CV: including acute myocardial infarction, stroke, all-cause mortality, CV mortality and a composite MACE endpoint.- Neoplasm endpoint: including the 10 most commonly occurring in the general population.Medical record abstraction for validation of a random sample of claims-identified cases is included.
• Study status:
  Finalised

Research institutions and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 17/09/2012

Actual: 17/09/2012

Study start date

Planned: 12/11/2012

Actual: 12/11/2012

Data analysis start date

Planned: 04/01/2013

Actual: 04/01/2013

Date of interim report, if expected

Planned: 17/06/2013

Actual: 17/06/2013

Date of final study report

Planned: 01/12/2014

Actual: 17/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Global Development, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)