I10.9
Conditions
Interventions
Group 1: Adult outpatients with essential hypertension who are treated with VIACORIND® according to indication.
In general, all planned examinations within this NIS shall only be conducted if they are
Sponsors
Servier GmbH Deutschland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - the patient has at least 18 years of age - the patient is treated with VIACORIND® in compliance with the summary of product characteristics - only patients for whom a therapy with VIACORIND® is clinically necessary and has already been planned before study start - the patient is informed about participating in this NIS and transfer of clinical data; his/her written informed consent is obtained
Exclusion criteria
Exclusion criteria: • Patients under 18 years of age and incapable of giving their consent must not participate in this study • Patients with contraindications according to the summary of prodcut characteristics must not participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Observation: approx. 3 months Documentation of data via standardized patient and physician questionnaires at 3 visits: baseline (V1, start of therapy), control examination (V2, approx. one month after V1) and final visit (V3, approx. 3 months after V1) Following questions are to be analyzed: 1) Influence of the VIACORIND® therapy on office BP (Blood pressure), home BP and ambulatory blood pressure measurement (ABPM, documentation at every visit (V1-V3)) 2) Influence of the VIACORIND® therapy on the laboratory parameters (total cholesterol, HDL, LDL, triglycerides, fasting glucose, HbA1c, urinary albumin, serum creatinine, serum sodium, serum potassium and serum uric acid; documentation at V1 and V3) 3) Influence of the VIACORIND® therapy on the concomitant treatments, esp. on the cardiovascular treatments (documentation at visit V1, V2 and V3) 4) Evaluation of the pill burden and blood pressure self-measurement (frequency) prior to and during therapy with VIACORIND® (documentation at V1 and V3) 5) Influence of the VIACORIND® therapy on therapy adherence (documentation at V1 and V3) 6) Evaluation of quality of sleep and personal disease burden (documentation at V1 and V3) 7) Gathering of knowledge regarding general tolerability and specific adverse events and adverse drug reactions under VIACORIND® therapy (documentation at V2 and V3) 8) General assessment of the VIACORIND® therapy in patients with essential Hypertension (documentation at V3) | — |
Secondary
| Measure | Time frame |
|---|---|
| no secondary endpoints defined | — |
Countries
Germany
Contacts
Public ContactRoland E. Schmieder
Kuratorium für Heimdialyse (KfH)
Outcome results
None listed