Sevikar HCT - treatment opportunity for patients with essential hypertension

Sevikar HCT - treatment opportunity for patients with essential hypertension - SeviTarget

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004396

Enrollment

8000

Registered

2012-11-20

Start date

2012-11-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA - 10015488: Essential hypertension I10

Interventions

Group 1: Patients with essential hypertension in which the onset of Sevikar HCT therapy is indicated according to SmPC. The observation period per patient is scheduled to a maximum of 24 ± 2 weeks.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The Sevikar HCT therapy should have been started less than 2 weeks before patients’ Baseline visit (V1). / Patient's written informed consent to participate before inclusion into the study.

Exclusion criteria

Exclusion criteria: The contraindications listed in the SmPC apply as exclusion criteria for participation in this NIS. Patients with secondary hypertension are excluded from participation in this NIS. Patients, for whom the onset of a treatment with the direct renin inhibitor Aliskiren is planned or for whom an existing Aliskiren treatment should be continued are excluded from participation in this NIS. Patients with planned or existing pregnancies are excluded from participation in this NIS.

Design outcomes

Primary

Measure	Time frame
To gain further insight into the safety profile of Sevikar HCT in daily practice by estimating the incidence of adverse drug reactions (ADRs), by evaluating the ADR profile, and by investigating possible correlations with concomitant medication.	—

Secondary

Measure	Time frame
To evaluate the efficacy within each of the Sevikar HCT dosages in daily practice (by measuring systolic and diastolic blood pressure and heart rate at every visit). / To evaluate patient compliance with Sevikar HCT in daily practice based on physician’s judgment. / To evaluate the efficacy and tolerability based on physician’s judgment. / To evaluate the influence of chronobiology on the efficacy andtolerability of Sevikar HCT in daily practice. / To evaluate the disease burden in hypertensive patients, as well as the general health status at visit 1 and at the final assessment [Hypertension-specific Questionnaire on Patients’ “Perceived Strain” by the High Blood Pressure (Part A) and on Patients’ Unspecific Symptoms (Part B) + SF-12 Health Survey]. / To gain further insight into pharmacoeconomic aspects of hypertension and antihypertensive therapy.	—

Measure

Time frame

To evaluate the efficacy within each of the Sevikar HCT dosages in daily practice (by measuring systolic and diastolic blood pressure and heart rate at every visit). / To evaluate patient compliance with Sevikar HCT in daily practice based on physician’s judgment. / To evaluate the efficacy and tolerability based on physician’s judgment. / To evaluate the influence of chronobiology on the efficacy andtolerability of Sevikar HCT in daily practice. / To evaluate the disease burden in hypertensive patients, as well as the general health status at visit 1 and at the final assessment [Hypertension-specific Questionnaire on Patients’ “Perceived Strain” by the High Blood Pressure (Part A) and on Patients’ Unspecific Symptoms (Part B) + SF-12 Health Survey]. / To gain further insight into pharmacoeconomic aspects of hypertension and antihypertensive therapy.

—

Countries

Austria, Germany

Contacts

Public ContactChristine Schober

Daiichi Sankyo Europe GmbH

christine.schober@daiichi-sankyo.eu+49-89-78080

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026