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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertensive patients | All eligible hypertensive patients treated with eprosartan |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions. | The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions. Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)] | Baseline up to 6 months |
| The Absolute Change in Systolic Blood Pressure From Baseline | The absolute change in systolic Blood Pressure from baseline | Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Framingham Stroke Risk Profile Scores of the Participating Patients | The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke. First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al. The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke. |
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Inclusion Criteria:
Adult patients (age greater or equal to 18 years)
Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines
Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice
Patients with at least one of the following conditions:
Exclusion Criteria:
1. Any contraindication to eprosartan or the excipients (according to the local label)
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Patients treated with eprosartan according to routine medical practice from hospitals and private physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Daskalaki, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 62499 | Agrinio | 30100 | Greece | |||
| Site Reference ID/Investigator# 62500 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypertensive Patients | All eligible hypertensive patients treated with eprosartan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline up to 6 months |
| Agrinio |
| 30100 |
| Greece |
| Site Reference ID/Investigator# 62577 | Alimos | 17456 | Greece |
| Site Reference ID/Investigator# 62386 | Athens | 10552 | Greece |
| Site Reference ID/Investigator# 62398 | Athens | 11143 | Greece |
| Site Reference ID/Investigator# 62389 | Athens | 11251 | Greece |
| Site Reference ID/Investigator# 62384 | Athens | 11521 | Greece |
| Site Reference ID/Investigator# 62392 | Chalandri | 15234 | Greece |
| Site Reference ID/Investigator# 62395 | Chalandri | 15234 | Greece |
| Site Reference ID/Investigator# 62391 | Chalandri | 34100 | Greece |
| Site Reference ID/Investigator# 62633 | Chalcis | 15236 | Greece |
| Site Reference ID/Investigator# 62629 | Chalcis | 34100 | Greece |
| Site Reference ID/Investigator# 62507 | Chania | 73132 | Greece |
| Site Reference ID/Investigator# 62508 | Chania | 73132 | Greece |
| Site Reference ID/Investigator# 62511 | Chania | 73132 | Greece |
| Site Reference ID/Investigator# 62588 | Chania | 73134 | Greece |
| Site Reference ID/Investigator# 62484 | Drama | 66100 | Greece |
| Site Reference ID/Investigator# 62518 | Eleftherio, Thessaloniki | 56334 | Greece |
| Site Reference ID/Investigator# 62512 | Euosmos, Thessaloniki | 56224 | Greece |
| Site Reference ID/Investigator# 62390 | Galatsi | 11147 | Greece |
| Site Reference ID/Investigator# 62584 | Glyfada | 16561 | Greece |
| Site Reference ID/Investigator# 62586 | Glyfada | 16561 | Greece |
| Site Reference ID/Investigator# 62589 | Heraklion | 18536 | Greece |
| Site Reference ID/Investigator# 62591 | Heraklion | 71305 | Greece |
| Site Reference ID/Investigator# 62505 | Heraklion | 71307 | Greece |
| Site Reference ID/Investigator# 62593 | Heraklion | 71307 | Greece |
| Site Reference ID/Investigator# 62587 | Heraklion | 71409 | Greece |
| Site Reference ID/Investigator# 62503 | Ioannina | 45221 | Greece |
| Site Reference ID/Investigator# 62497 | Ioannina | 45332 | Greece |
| Site Reference ID/Investigator# 62493 | Ioannina | 45444 | Greece |
| Site Reference ID/Investigator# 62487 | Kalamata | 24100 | Greece |
| Site Reference ID/Investigator# 62580 | Kallithea | 17672 | Greece |
| Site Reference ID/Investigator# 62645 | Kavala | 65302 | Greece |
| Site Reference ID/Investigator# 62644 | Kavala | 65403 | Greece |
| Site Reference ID/Investigator# 62483 | Komotini | 67100 | Greece |
| Site Reference ID/Investigator# 62642 | Komotini | 69100 | Greece |
| Site Reference ID/Investigator# 62575 | Korydallos | 18120 | Greece |
| Site Reference ID/Investigator# 62631 | Lamia | 35100 | Greece |
| Site Reference ID/Investigator# 62635 | Lamia | 35100 | Greece |
| Site Reference ID/Investigator# 62626 | Larissa | 41221 | Greece |
| Site Reference ID/Investigator# 62638 | Larissa | 41221 | Greece |
| Site Reference ID/Investigator# 62628 | Larissa | 41222 | Greece |
| Site Reference ID/Investigator# 62637 | Larissa | 41223 | Greece |
| Site Reference ID/Investigator# 62574 | Megara | 19100 | Greece |
| Site Reference ID/Investigator# 62630 | N. Ionia Volou | 38446 | Greece |
| Site Reference ID/Investigator# 62397 | Néa Erythraía | 14671 | Greece |
| Site Reference ID/Investigator# 62385 | Néa Filadélfeia | 14671 | Greece |
| Site Reference ID/Investigator# 62399 | Néa Smýrni | 17121 | Greece |
| Site Reference ID/Investigator# 62582 | Nikaia | 18450 | Greece |
| Site Reference ID/Investigator# 62585 | P. Faliro | 17564 | Greece |
| Site Reference ID/Investigator# 62393 | Paianía | 19002 | Greece |
| Site Reference ID/Investigator# 62394 | Pallini | 15351 | Greece |
| Site Reference ID/Investigator# 62522 | Panórama | 55236 | Greece |
| Site Reference ID/Investigator# 62501 | Pátrai | 26221 | Greece |
| Site Reference ID/Investigator# 62502 | Pátrai | 26221 | Greece |
| Site Reference ID/Investigator# 62492 | Pátrai | 26442 | Greece |
| Site Reference ID/Investigator# 62401 | Peristeri | 12132 | Greece |
| Site Reference ID/Investigator# 62402 | Peristeri | 12136 | Greece |
| Site Reference ID/Investigator# 62578 | Peristeri | 12136 | Greece |
| Site Reference ID/Investigator# 62388 | Peuki | 15121 | Greece |
| Site Reference ID/Investigator# 62396 | Peuki | 15121 | Greece |
| Site Reference ID/Investigator# 62579 | Piraeus | 18536 | Greece |
| Site Reference ID/Investigator# 62520 | Polykastro | 61200 | Greece |
| Site Reference ID/Investigator# 62495 | Pýrgos | 27100 | Greece |
| Site Reference ID/Investigator# 62496 | Pýrgos | 27100 | Greece |
| Site Reference ID/Investigator# 62510 | Rhodes | 85100 | Greece |
| Site Reference ID/Investigator# 62590 | Rhodes | 85100 | Greece |
| Site Reference ID/Investigator# 62592 | Rhodes | 85100 | Greece |
| Site Reference ID/Investigator# 62640 | Sappes Komotinis | 69100 | Greece |
| Site Reference ID/Investigator# 62641 | Serres | 62122 | Greece |
| Site Reference ID/Investigator# 62513 | Sykiés | 56626 | Greece |
| Site Reference ID/Investigator# 62509 | Thermi, Thessaloniki | 57001 | Greece |
| Site Reference ID/Investigator# 62514 | Thessaloniki | 54022 | Greece |
| Site Reference ID/Investigator# 62517 | Thessaloniki | 54623 | Greece |
| Site Reference ID/Investigator# 62516 | Thessaloniki | 55132 | Greece |
| Site Reference ID/Investigator# 62521 | Thessaloniki | 63077 | Greece |
| Site Reference ID/Investigator# 62523 | Thessaloniki | 63200 | Greece |
| Site Reference ID/Investigator# 62506 | Véria | 59100 | Greece |
| Site Reference ID/Investigator# 62627 | Volos | 38221 | Greece |
| Site Reference ID/Investigator# 62634 | Volos | 38221 | Greece |
| Site Reference ID/Investigator# 62486 | Vraxnaiika | 25002 | Greece |
| Site Reference ID/Investigator# 62387 | Výronas | 16233 | Greece |
| Site Reference ID/Investigator# 62485 | Xánthi | 67100 | Greece |
| Site Reference ID/Investigator# 62488 | Xánthi | 69300 | Greece |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertensive Patients | All eligible hypertensive patients treated with eprosartan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions. | The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions. Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)] | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to 6 months |
|
|
| ||||||||||||||||||||||||||
| Primary | The Absolute Change in Systolic Blood Pressure From Baseline | The absolute change in systolic Blood Pressure from baseline | Posted | Mean | Standard Deviation | mmHg | Baseline up to 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change in Framingham Stroke Risk Profile Scores of the Participating Patients | The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke. First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al. The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke. | Excluded from Framingham calculation were patients with either
| Posted | Median | Full Range | score on a scale | Baseline up to 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypertensive Patients | All eligible hypertensive patients treated with eprosartan | 0 | 533 | 7 | 533 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dizziness | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
No important limitations apply. Missing data and drop-out rate was very low; but some factors required for patient CV (cardiovascular) risk classification were unknown and may have resulted in CV risk underestimation in a limited number of patients.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taco Baardman | Abbott | taco.baardman@abbott.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Participants |
|
|