Arterial Hypertension
Conditions
Brief summary
Efficacy: Estimation of the percentage of patients who achieved the target SBP, according to the ESC/ESH guidelines for hypertension (2023) and based on Investigator’s judgment, at the following time points from the start of the intervention: 8- 10 weeks and 16 weeks., Safety: Assessment of adverse events (treatment-related AEs leading to temporary or permanent discontinuation of study drug administration, clinically significant AEs, and SAEs regardless of causality), within 16 weeks from the start of the intervention or until the start of a new antihypertensive lawsuit (whichever occurs first)., Patient compliance
Detailed description
Percentage of patients who needed the addition of a 3rd drug for controlling their BP during the follow-up period (16 weeks)., Correlation of study drug efficacy with the patient-reported, average value of home blood pressure monitoring (HBPM).
Interventions
DRUGCombipress 150 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία
DRUGCombipress 150 mg/10 mg επικαλυμμένα με λεπτό υμένιο δισκία
DRUGCombipress 300 mg/10 mg επικαλυμμένα με λεπτό υμένιο δισκία
DRUGCombipress 300 mg/5 mg επικαλυμμένα με λεπτό υμένιο δισκία
Sponsors
Win Medica Pharmaceutical S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Estimation of the percentage of patients who achieved the target SBP, according to the ESC/ESH guidelines for hypertension (2023) and based on Investigator’s judgment, at the following time points from the start of the intervention: 8- 10 weeks and 16 weeks., Safety: Assessment of adverse events (treatment-related AEs leading to temporary or permanent discontinuation of study drug administration, clinically significant AEs, and SAEs regardless of causality), within 16 weeks from the start of the intervention or until the start of a new antihypertensive lawsuit (whichever occurs first)., Patient compliance | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who needed the addition of a 3rd drug for controlling their BP during the follow-up period (16 weeks)., Correlation of study drug efficacy with the patient-reported, average value of home blood pressure monitoring (HBPM). | — |
Countries
Greece
Outcome results
None listed