Study identification

PURI

https://redirect.ema.europa.eu/resource/9350

EU PAS number

EUPAS3177

Study ID

9350

Official title and acronym

SEVIKAR HCT - treatment opportunity for patients with essential hypertension (SeviTarget)

DARWIN EU® study

No

Study countries

Austria
Germany

Study description

Multi-national, open, prospective multi-center observational (non-interventional) study without any intervention by the sponsor regarding the selection of patients, diagnostic procedures or therapeutic decisions. / The observation period per patient is scheduled to a maximum of 24 ± 2 weeks. SEVIKAR HCT will be prescribed according to Summary of Product Characteristics. / Primary objective: To further investigate the safety profile of SEVIKAR HCT in daily practice and to collect data on so far unexpected adverse reactions as well as possible interactions with concomitant medications. / Secondary objectives are the efficacy within each of the Sevikar HCT dosages, patient compliance based on physician’s judgment, the disease burden in hypertensive patients, as well as the influence of chronobiological aspects on the tolerability and efficacy of the antihypertensive therapy.

Study status

Finalised
Research institutions and networks

Institutions

Dr. Bramlage & Dr. Hankowitz Partnerschaft
Multiple centres: 999 centres are involved in the study
In total, 1100 centers are planned to be involved.

Contact details

Christine Schober

Primary lead investigator
Study timelines

Date when funding contract was signed

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

Daiichi Sankyo European affiliates and Daiichi Sankyo Europe GmbH
Regulatory

Was the study required by a regulatory body?

No