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 institution and networks

Institutions

Contact details

Clinical Disclosure Officer Novartis

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG
Study protocol
Initial protocol
English (637.02 KB - PDF)View document
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)