Study identification

PURI

https://redirect.ema.europa.eu/resource/17554

EU PAS number

EUPAS4963

Study ID

17554

Official title and acronym

Angioedema among patients with hypertension treated with aliskiren or other anti-hypertensive medications in the US – a cohort Study and a nested case-control analysis using health claims data

DARWIN EU® study

No

Study countries

United States

Study description

Retrospective database cohort study including a nested case-control analysis with secondary use of data from the IMS PharMetrics PlusTM claims database from the United States in adult hypertensive patients (18+ years of age) with a prescription for an anti-hypertensive medication of interest between July 1, 2007 and September 30, 2012. The primary objective is to assess the annual prevalence and incidence rates of angioedema in treated hypertensive patients among a commercially insured population, stratified by the anti-hypertensive medication filled. The secondary objective is to explore the relative risk of experiencing angioedema among patients prescribed aliskiren compared with other anti-hypertensive medications.

Study status

Finalised
Research institutions and networks

Institutions

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

CSPP100A2415-Redacted-Protocol_15Aug2013

English (3.22 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)