Sevikar HCT - treatment opportunity for patients with essential hypertensio
- Conditions
- MedDRA - 10015488: Essential hypertensionI10Essential (primary) hypertension
- Registration Number
- DRKS00004396
- Lead Sponsor
- Daiichi Sankyo Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5799
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.