Study identification

PURI

https://redirect.ema.europa.eu/resource/46491

EU PAS number

EUPAS13232

Study ID

46491

Official title and acronym

SHP617-404: A SWEDISH RETROSPECTIVE STUDY EVALUATING THE PATTERN OF PLENADREN USE FROM SWEDISH QUALITY REGISTRIES (SWE-DUS)

DARWIN EU® study

No

Study countries

Sweden

Study description

THE STUDY DID NEVER START AND NO PATIENTS WERE ENROLLED. This is an open-ended, non-interventional, retrospective, drug utilization study which will assess data extracted from the Swedish National Quality Register regarding drug prescribing patterns, including any off-label use of PLENADREN. Data will be obtained from 2 registries within the Swedish National Quality Register, the National Patient Register (NPR, includes both inpatient and outpatient information) and the National Pharmaceutical Drug Register (NPDR). Data will be extracted from the registries after the launch of PLENADREN in Sweden (01 November 2012) and as soon as the number of patients treated with PLENADREN is estimated to be sufficient to perform an analysis, and will continue once yearly until the study is discontinued. PLENADREN is reported to be used off-label in adults for the treatment of the condition “adrenal fatigue”, which is not a medically distinct syndrome.

Study status

Finalised
Research institutions and networks

Institutions

Shire
First published:
01/02/2024
Institution

Contact details

Call Center Shire

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

Shire
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)