Study identification

PURI

https://redirect.ema.europa.eu/resource/17559

EU PAS number

EUPAS4568

Study ID

17559

Official title and acronym

Assessing the Incidence of Ischemic Colitis in Treated Adult Hypertensive Patients in the United States – a Descriptive, Retrospective Cohort Study with Secondary Use of Data from a US Health Claims Database (NA)

DARWIN EU® study

No

Study countries

United States

Study description

Descriptive, retrospective cohort study with secondary use of data derived from the PharMetricsTM Health Plan Claims Database from 1 July 2005 through 30 June 2012 (or the most recent data available at the time of data extraction). The objective of this study is to assess the incidence of probable ischemic colitis (defined as evidence of a recorded diagnosis of ischemic colitis within 3 months after a colonoscopy, rectosigmoidoscopy or a colectomy) in treated hypertensive patients (focusing on patients using aliskiren) and by demographic characteristics, antihypertensive therapy use over the follow-up period, and adherence to antihypertensive therapy. Additionally, we will also look for incidence of probable ischemic colitis within a sample of the general population (patients without a diagnosis of hypertension or antihypertensive drug use).

Study status

Finalised
Research institution and networks

Institutions

Novartis Pharmaceuticals

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

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

CSPP100A2416-Redacted-Protocol_26Jun2013

English (3.16 MB - PDF)View document
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)