A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan

August 8, 2014 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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)

Study Type

Observational

Enrollment (Actual)

533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Agrinio, Greece, 30100
        • Site Reference ID/Investigator# 62499
      • Agrinio, Greece, 30100
        • Site Reference ID/Investigator# 62500
      • Alimos, Greece, 17456
        • Site Reference ID/Investigator# 62577
      • Athens, Greece, 10552
        • Site Reference ID/Investigator# 62386
      • Athens, Greece, 11143
        • Site Reference ID/Investigator# 62398
      • Athens, Greece, 11251
        • Site Reference ID/Investigator# 62389
      • Athens, Greece, 11521
        • Site Reference ID/Investigator# 62384
      • Chalandri, Greece, 15234
        • Site Reference ID/Investigator# 62392
      • Chalandri, Greece, 15234
        • Site Reference ID/Investigator# 62395
      • Chalandri, Greece, 34100
        • Site Reference ID/Investigator# 62391
      • Chalkida, Greece, 15236
        • Site Reference ID/Investigator# 62633
      • Chalkida, Greece, 34100
        • Site Reference ID/Investigator# 62629
      • Chania, Greece, 73132
        • Site Reference ID/Investigator# 62507
      • Chania, Greece, 73132
        • Site Reference ID/Investigator# 62508
      • Chania, Greece, 73132
        • Site Reference ID/Investigator# 62511
      • Chania, Greece, 73134
        • Site Reference ID/Investigator# 62588
      • Drama, Greece, 66100
        • Site Reference ID/Investigator# 62484
      • Eleftherio, Thessaloniki, Greece, 56334
        • Site Reference ID/Investigator# 62518
      • Euosmos, Thessaloniki, Greece, 56224
        • Site Reference ID/Investigator# 62512
      • Galatsi, Greece, 11147
        • Site Reference ID/Investigator# 62390
      • Glyfada, Greece, 16561
        • Site Reference ID/Investigator# 62584
      • Glyfada, Greece, 16561
        • Site Reference ID/Investigator# 62586
      • Heraklion, Greece, 18536
        • Site Reference ID/Investigator# 62589
      • Heraklion, Greece, 71305
        • Site Reference ID/Investigator# 62591
      • Heraklion, Greece, 71307
        • Site Reference ID/Investigator# 62505
      • Heraklion, Greece, 71307
        • Site Reference ID/Investigator# 62593
      • Heraklion, Greece, 71409
        • Site Reference ID/Investigator# 62587
      • Ioannina, Greece, 45221
        • Site Reference ID/Investigator# 62503
      • Ioannina, Greece, 45332
        • Site Reference ID/Investigator# 62497
      • Ioannina, Greece, 45444
        • Site Reference ID/Investigator# 62493
      • Kalamata, Greece, 24100
        • Site Reference ID/Investigator# 62487
      • Kallithea, Greece, 17672
        • Site Reference ID/Investigator# 62580
      • Kavala, Greece, 65302
        • Site Reference ID/Investigator# 62645
      • Kavala, Greece, 65403
        • Site Reference ID/Investigator# 62644
      • Komotini, Greece, 67100
        • Site Reference ID/Investigator# 62483
      • Komotini, Greece, 69100
        • Site Reference ID/Investigator# 62642
      • Korydallos, Greece, 18120
        • Site Reference ID/Investigator# 62575
      • Lamia, Greece, 35100
        • Site Reference ID/Investigator# 62631
      • Lamia, Greece, 35100
        • Site Reference ID/Investigator# 62635
      • Larisa, Greece, 41221
        • Site Reference ID/Investigator# 62626
      • Larisa, Greece, 41221
        • Site Reference ID/Investigator# 62638
      • Larisa, Greece, 41222
        • Site Reference ID/Investigator# 62628
      • Larisa, Greece, 41223
        • Site Reference ID/Investigator# 62637
      • Megara, Greece, 19100
        • Site Reference ID/Investigator# 62574
      • N. Ionia Volou, Greece, 38446
        • Site Reference ID/Investigator# 62630
      • Nea Erythraia, Greece, 14671
        • Site Reference ID/Investigator# 62397
      • Nea Filadelfeia, Greece, 14671
        • Site Reference ID/Investigator# 62385
      • Nea Smyrni, Greece, 17121
        • Site Reference ID/Investigator# 62399
      • Nikaia, Greece, 18450
        • Site Reference ID/Investigator# 62582
      • P. Faliro, Greece, 17564
        • Site Reference ID/Investigator# 62585
      • Paiania, Greece, 19002
        • Site Reference ID/Investigator# 62393
      • Pallini, Greece, 15351
        • Site Reference ID/Investigator# 62394
      • Panorama, Greece, 55236
        • Site Reference ID/Investigator# 62522
      • Patras, Greece, 26221
        • Site Reference ID/Investigator# 62501
      • Patras, Greece, 26221
        • Site Reference ID/Investigator# 62502
      • Patras, Greece, 26442
        • Site Reference ID/Investigator# 62492
      • Peiraias, Greece, 18536
        • Site Reference ID/Investigator# 62579
      • Peristeri, Greece, 12132
        • Site Reference ID/Investigator# 62401
      • Peristeri, Greece, 12136
        • Site Reference ID/Investigator# 62402
      • Peristeri, Greece, 12136
        • Site Reference ID/Investigator# 62578
      • Peuki, Greece, 15121
        • Site Reference ID/Investigator# 62388
      • Peuki, Greece, 15121
        • Site Reference ID/Investigator# 62396
      • Polykastro, Greece, 61200
        • Site Reference ID/Investigator# 62520
      • Pyrgos, Greece, 27100
        • Site Reference ID/Investigator# 62495
      • Pyrgos, Greece, 27100
        • Site Reference ID/Investigator# 62496
      • Rodes, Greece, 85100
        • Site Reference ID/Investigator# 62510
      • Rodes, Greece, 85100
        • Site Reference ID/Investigator# 62590
      • Rodes, Greece, 85100
        • Site Reference ID/Investigator# 62592
      • Sappes Komotinis, Greece, 69100
        • Site Reference ID/Investigator# 62640
      • Serres, Greece, 62122
        • Site Reference ID/Investigator# 62641
      • Sykies, Greece, 56626
        • Site Reference ID/Investigator# 62513
      • Thermi, Thessaloniki, Greece, 57001
        • Site Reference ID/Investigator# 62509
      • Thessaloniki, Greece, 54022
        • Site Reference ID/Investigator# 62514
      • Thessaloniki, Greece, 54623
        • Site Reference ID/Investigator# 62517
      • Thessaloniki, Greece, 55132
        • Site Reference ID/Investigator# 62516
      • Thessaloniki, Greece, 63077
        • Site Reference ID/Investigator# 62521
      • Thessaloniki, Greece, 63200
        • Site Reference ID/Investigator# 62523
      • Veria, Greece, 59100
        • Site Reference ID/Investigator# 62506
      • Volos, Greece, 38221
        • Site Reference ID/Investigator# 62627
      • Volos, Greece, 38221
        • Site Reference ID/Investigator# 62634
      • Vraxnaiika, Greece, 25002
        • Site Reference ID/Investigator# 62486
      • Vyronas, Greece, 16233
        • Site Reference ID/Investigator# 62387
      • Xanthi, Greece, 67100
        • Site Reference ID/Investigator# 62485
      • Xanthi, Greece, 69300
        • Site Reference ID/Investigator# 62488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with eprosartan according to routine medical practice from hospitals and private physicians.

Description

Inclusion Criteria:

  1. Adult patients (age greater or equal to 18 years)
  2. 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
  3. Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice

  4. Patients with at least one of the following conditions:

    • Newly diagnosed hypertension,
    • Inability to tolerate other antihypertensive medications, or
    • Lack of response to current antihypertensive medication(s)

Exclusion Criteria:

1. Any contraindication to eprosartan or the excipients (according to the local label)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hypertensive patients
All eligible hypertensive patients treated with eprosartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Baseline up to 6 months

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
Time Frame: Baseline up to 6 months
The absolute change in systolic Blood Pressure from baseline
Baseline up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Framingham Stroke Risk Profile Scores of the Participating Patients
Time Frame: Baseline up to 6 months

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.
Baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Maria Daskalaki, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13-165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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