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HypertensionNCT01562613

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

An observational study of Hypertension and Stroke, run by Abbott at 84 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Stroke
How many people
533 participants
Where
84 sitesGreece
Study dates
Mar 2012to Mar 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

84 sites in 1 country.

84 sites in 1 country

Greece84 sites

  • Site Reference ID/Investigator# 62499

    Agrinio, 30100

  • Site Reference ID/Investigator# 62500

    Agrinio, 30100

  • Site Reference ID/Investigator# 62577

    Alimos, 17456

  • Site Reference ID/Investigator# 62386

    Athens, 10552

  • Site Reference ID/Investigator# 62398

    Athens, 11143

  • Site Reference ID/Investigator# 62389

    Athens, 11251

  • Site Reference ID/Investigator# 62384

    Athens, 11521

  • Site Reference ID/Investigator# 62392

    Chalandri, 15234

  • Site Reference ID/Investigator# 62395

    Chalandri, 15234

  • Site Reference ID/Investigator# 62391

    Chalandri, 34100

  • Site Reference ID/Investigator# 62633

    Chalcis, 15236

  • Site Reference ID/Investigator# 62629

    Chalcis, 34100

  • Site Reference ID/Investigator# 62507

    Chania, 73132

  • Site Reference ID/Investigator# 62508

    Chania, 73132

  • Site Reference ID/Investigator# 62511

    Chania, 73132

  • Site Reference ID/Investigator# 62588

    Chania, 73134

  • Site Reference ID/Investigator# 62484

    Drama, 66100

  • Site Reference ID/Investigator# 62518

    Eleftherio, Thessaloniki, 56334

  • Site Reference ID/Investigator# 62512

    Euosmos, Thessaloniki, 56224

  • Site Reference ID/Investigator# 62390

    Galatsi, 11147

  • Site Reference ID/Investigator# 62584

    Glyfada, 16561

  • Site Reference ID/Investigator# 62586

    Glyfada, 16561

  • Site Reference ID/Investigator# 62589

    Heraklion, 18536

  • Site Reference ID/Investigator# 62591

    Heraklion, 71305

  • Site Reference ID/Investigator# 62505

    Heraklion, 71307

  • Site Reference ID/Investigator# 62593

    Heraklion, 71307

  • Site Reference ID/Investigator# 62587

    Heraklion, 71409

  • Site Reference ID/Investigator# 62503

    Ioannina, 45221

  • Site Reference ID/Investigator# 62497

    Ioannina, 45332

  • Site Reference ID/Investigator# 62493

    Ioannina, 45444

  • Site Reference ID/Investigator# 62487

    Kalamata, 24100

  • Site Reference ID/Investigator# 62580

    Kallithea, 17672

  • Site Reference ID/Investigator# 62645

    Kavala, 65302

  • Site Reference ID/Investigator# 62644

    Kavala, 65403

  • Site Reference ID/Investigator# 62483

    Komotini, 67100

  • Site Reference ID/Investigator# 62642

    Komotini, 69100

  • Site Reference ID/Investigator# 62575

    Korydallos, 18120

  • Site Reference ID/Investigator# 62631

    Lamia, 35100

  • Site Reference ID/Investigator# 62635

    Lamia, 35100

  • Site Reference ID/Investigator# 62626

    Larissa, 41221

  • Site Reference ID/Investigator# 62638

    Larissa, 41221

  • Site Reference ID/Investigator# 62628

    Larissa, 41222

  • Site Reference ID/Investigator# 62637

    Larissa, 41223

  • Site Reference ID/Investigator# 62574

    Megara, 19100

  • Site Reference ID/Investigator# 62630

    N. Ionia Volou, 38446

  • Site Reference ID/Investigator# 62397

    Néa Erythraía, 14671

  • Site Reference ID/Investigator# 62385

    Néa Filadélfeia, 14671

  • Site Reference ID/Investigator# 62399

    Néa Smýrni, 17121

  • Site Reference ID/Investigator# 62582

    Nikaia, 18450

  • Site Reference ID/Investigator# 62585

    P. Faliro, 17564

  • Site Reference ID/Investigator# 62393

    Paianía, 19002

  • Site Reference ID/Investigator# 62394

    Pallini, 15351

  • Site Reference ID/Investigator# 62522

    Panórama, 55236

  • Site Reference ID/Investigator# 62501

    Pátrai, 26221

  • Site Reference ID/Investigator# 62502

    Pátrai, 26221

  • Site Reference ID/Investigator# 62492

    Pátrai, 26442

  • Site Reference ID/Investigator# 62401

    Peristeri, 12132

  • Site Reference ID/Investigator# 62402

    Peristeri, 12136

  • Site Reference ID/Investigator# 62578

    Peristeri, 12136

  • Site Reference ID/Investigator# 62388

    Peuki, 15121

  • Site Reference ID/Investigator# 62396

    Peuki, 15121

  • Site Reference ID/Investigator# 62579

    Piraeus, 18536

  • Site Reference ID/Investigator# 62520

    Polykastro, 61200

  • Site Reference ID/Investigator# 62495

    Pýrgos, 27100

  • Site Reference ID/Investigator# 62496

    Pýrgos, 27100

  • Site Reference ID/Investigator# 62510

    Rhodes, 85100

  • Site Reference ID/Investigator# 62590

    Rhodes, 85100

  • Site Reference ID/Investigator# 62592

    Rhodes, 85100

  • Site Reference ID/Investigator# 62640

    Sappes Komotinis, 69100

  • Site Reference ID/Investigator# 62641

    Serres, 62122

  • Site Reference ID/Investigator# 62513

    Sykiés, 56626

  • Site Reference ID/Investigator# 62509

    Thermi, Thessaloniki, 57001

  • Site Reference ID/Investigator# 62514

    Thessaloniki, 54022

  • Site Reference ID/Investigator# 62517

    Thessaloniki, 54623

  • Site Reference ID/Investigator# 62516

    Thessaloniki, 55132

  • Site Reference ID/Investigator# 62521

    Thessaloniki, 63077

  • Site Reference ID/Investigator# 62523

    Thessaloniki, 63200

  • Site Reference ID/Investigator# 62506

    Véria, 59100

  • Site Reference ID/Investigator# 62627

    Volos, 38221

  • Site Reference ID/Investigator# 62634

    Volos, 38221

  • Site Reference ID/Investigator# 62486

    Vraxnaiika, 25002

  • Site Reference ID/Investigator# 62387

    Výronas, 16233

  • Site Reference ID/Investigator# 62485

    Xánthi, 67100

  • Site Reference ID/Investigator# 62488

    Xánthi, 69300

Other trials in Greece

About this study

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.

Read the 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)
Conditions
Hypertension, Stroke
Keywords
Stroke, Hypertension
Medical subject headings
Hypertension, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01562613
Study groupRoleWhat they receive
Hypertensive patientsAll eligible hypertensive patients treated with eprosartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)]

    Measured: Baseline up to 6 months

  2. The Absolute Change in Systolic Blood Pressure From Baseline

    The absolute change in systolic Blood Pressure from baseline

    Measured: Baseline up to 6 months

Secondary outcomes (1)

  1. 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.

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01562613
Sponsor's protocol ID
P13-165
Status last verified
Aug 2014
First submitted
16 Mar 2012
Last updated
12 Aug 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Stroke, run by Abbott at 84 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01562613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.

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