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

Study identification

• 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

Institut für Pharmakologie und präventive Medizin

Dr. Bramlage & Dr. Hankowitz Partnerschaft

Multiple centres: 999 centres are involved in the study
In total, 1100 centers are planned to be involved.

Study timelines

Date when funding contract was signed

Actual:15/02/2012

Study start date

Planned:26/11/2012

Actual:26/11/2012

Date of final study report

Planned:31/03/2015

Actual:09/12/2014

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