DARWIN EU® - Representativeness of the clinical trial population compared with the real-world population with resistant hypertension

17/07/2026
17/07/2026
EU PAS number:
EUPAS1000001065
Study
Ongoing
Subscribe
Download as PDF
Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000001065

Study ID

1000001065

Official title and acronym

DARWIN EU® - Representativeness of the clinical trial population compared with the real-world population with resistant hypertension

DARWIN EU® study

Yes

Study countries

Belgium
Denmark
Finland
Netherlands
Spain
United States

Study description

Resistant hypertension is defined by elevated systolic and diastolic blood pressure values despite concomitant use of at least three antihypertensive drugs of different classes, usually including ACE-inhibitors/angiotensin receptor blockers, calcium channel antagonists, and diuretics, and is associated with an increased risk of myocardial infarction, stroke, end-stage renal disease, and death. Baxdrostat, an aldosterone synthase inhibitor, is under evaluation for marketing authorisation for the treatment of resistant hypertension. A recent clinical trial examined its efficacy and safety in individuals with uncontrolled or resistant hypertension. This study aims to assess the representativeness of the Baxdrostat trial population with resistant hypertension by estimating the demographic, clinical, and treatment characteristics of the real-world population with resistant hypertension.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ellen Gerritsen

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