Study identification

EU PAS number

EUPAS1000000768

Study ID

1000000768

Official title and acronym

DARWIN EU® - Characterisation of aliskiren users

DARWIN EU® study

Yes

Study countries

Denmark
Netherlands
Spain
United Kingdom

Study description

Existing evidence from case reports and preclinical data raised concerns regarding the atrial and ventricular proarrhythmic potential of aliskiren, especially with underlying risk of atrial fibrillation. However, little is known about the usage of aliskiren in clinical practice, in particular characteristics of aliskiren users.
This study aims to characterise new aliskiren users to inform the planning and feasibility of a potential future safety study investigating risk of cardiac events.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Amy Lam

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable