Incidence of colorectal hyperplasia and gastrointestinal cancer in treated adult hypertensive patients in the United States – a cohort study based on secondary use of health data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17572
• EU PAS number:
  EUPAS7828
• Study ID:
  17572
• Official title and acronym:
  Incidence of colorectal hyperplasia and gastrointestinal cancer in treated adult hypertensive patients in the United States – a cohort study based on secondary use of health data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institution and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 25/06/2013

Actual: 25/06/2013

Study start date

Planned: 01/11/2014

Actual: 01/07/2014

Date of final study report

Planned: 30/06/2015

Actual: 27/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma Services AG

Study protocol

Initial protocol

SPP100A2418-v0--protocol-revised-24Mar14PRACapproved 20140703_Redacted

Updated protocol

CSPP100A2418-Redacted-Protocol

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)

Other study registration identification numbers and links

CSPP100A2418