Stroke Clinical Trial
Official title:
Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)
The primary objective of the study is to evaluate the proportion of hypertensive patients
who achieve regulation of their blood pressure (BP) levels according to the European Society
of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with
eprosartan for 6 months under standard medical practice conditions. The absolute change in
Systolic blood pressure from baseline will also be calculated.
This study also aims in the evaluation of Framingham stroke risk profile score of patients
treated with eprosartan under standard clinical practice conditions during the observation
period. Besides the primary and the secondary objective of the study, the assessment of the
percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs),
Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per
observed event) and the percentage of patients who discontinued treatment prematurely before
the advent of the 6-month observation period due to toxicity to the study medication
constitutes another important objective that is related to the safety of the treatment.
This is an open, non-interventional, non-comparative study. Therefore, there is no control
group, randomization, or blinding involved. The target subject population is hypertensive
patients who are being treated with eprosartan under standard clinical conditions and the
locally approved Summary of Product Characteristics (SmPCs). Treatment selection is
independent of the study conduct according to the local requirements of the Health
Authorities for the definition of non-interventional studies being conducted in Greece.
Therefore, the inclusion/exclusion criteria of this study follow the clinical decision of
the participating physician, when prescribing the study medication(s) under standard
clinical practice. The study plans to enroll 600 patients from 100 participating centers
(hospitals and private physicians). This number includes an additional 25% cushion compared
to the required sample size to ensure that sufficient data is collected for the subsequent
statistical analysis. The study has been designed to be non-interventional and subsequently
follows the per center standard practice of treatment, medical care and visits. As a result
a rigid visit schedule could not be imposed. However, when taking into account the overall
local standard practice, an overview of the visit schedule is indicated per subject:
- A baseline visit at the beginning of the 6-month observation period where the
investigator will check the eligibility of the subject and will record the baseline
data provided that the subject is eligible and has given the signed and dated informed
consent.
- A final visit at the end of the 6-month treatment period (also observation period), and
- At least one interim visit (according to the standard clinical practice, within
baseline and final visit)
;
Time Perspective: Prospective
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