A multi-database cohort study to assess the incidence rates of colorectal hyperplasia among hypertensive patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17564
• EU PAS number:
  EUPAS8295
• Study ID:
  17564
• Official title and acronym:
  A multi-database cohort study to assess the incidence rates of colorectal hyperplasia among hypertensive patients
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  This study will estimate the frequency of colorectal polyps, cysts and neoplasms among hypertensive patients. Age- and sex-specific incidence rates will be estimated as well as the time from hypertension diagnosis to colorectal polyps, colorectal cysts and colorectal neoplasms.This multi-database dynamic cohort study, in four European primary care databases (CPRD, IPCI, CPRD, SIDIAP), includes all adult patients (aged 18-79 years) with an incident diagnosis of arterial hypertension.Incidence rates will be calculated by dividing the total number of incident cases over the total number of person-years at risk within the study population for each database separately.. Standardization of incidence rates will be performed using either a European reference population or by internal validation using one of the four databases as reference population to which the other three databases will be compared to.Kaplan Meier analyses will be performed to estimate the survival time from arterial hypertension diagnosis date until one of the primary safety endpoints (colorectal polyps, cysts or neoplasms) but also for each of the endpoints separately.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 01/01/2015

Actual: 09/01/2015

Study start date

Planned: 01/01/2015

Actual: 15/05/2015

Date of final study report

Planned: 01/01/2016

Actual: 14/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Study protocol

Initial protocol

CSPP100A2417-Redacted-Protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CSPP100A2417