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

NCT ID: NCT01562613

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 533 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-03-31

Brief 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 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.

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Hypertensive patients

All eligible hypertensive patients treated with eprosartan

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Daskalaki, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 62499

Agrinio, , Greece

Site Reference ID/Investigator# 62500

Agrinio, , Greece

Site Reference ID/Investigator# 62577

Alimos, , Greece

Site Reference ID/Investigator# 62386

Athens, , Greece

Site Reference ID/Investigator# 62398

Athens, , Greece

Site Reference ID/Investigator# 62389

Athens, , Greece

Site Reference ID/Investigator# 62384

Athens, , Greece

Site Reference ID/Investigator# 62392

Chalandri, , Greece

Site Reference ID/Investigator# 62395

Chalandri, , Greece

Site Reference ID/Investigator# 62391

Chalandri, , Greece

Site Reference ID/Investigator# 62633

Chalcis, , Greece

Site Reference ID/Investigator# 62629

Chalcis, , Greece

Site Reference ID/Investigator# 62507

Chania, , Greece

Site Reference ID/Investigator# 62508

Chania, , Greece

Site Reference ID/Investigator# 62511

Chania, , Greece

Site Reference ID/Investigator# 62588

Chania, , Greece

Site Reference ID/Investigator# 62484

Drama, , Greece

Site Reference ID/Investigator# 62518

Eleftherio, Thessaloniki, , Greece

Site Reference ID/Investigator# 62512

Euosmos, Thessaloniki, , Greece

Site Reference ID/Investigator# 62390

Galatsi, , Greece

Site Reference ID/Investigator# 62584

Glyfada, , Greece

Site Reference ID/Investigator# 62586

Glyfada, , Greece

Site Reference ID/Investigator# 62589

Heraklion, , Greece

Site Reference ID/Investigator# 62591

Heraklion, , Greece

Site Reference ID/Investigator# 62505

Heraklion, , Greece

Site Reference ID/Investigator# 62593

Heraklion, , Greece

Site Reference ID/Investigator# 62587

Heraklion, , Greece

Site Reference ID/Investigator# 62503

Ioannina, , Greece

Site Reference ID/Investigator# 62497

Ioannina, , Greece

Site Reference ID/Investigator# 62493

Ioannina, , Greece

Site Reference ID/Investigator# 62487

Kalamata, , Greece

Site Reference ID/Investigator# 62580

Kallithea, , Greece

Site Reference ID/Investigator# 62645

Kavala, , Greece

Site Reference ID/Investigator# 62644

Kavala, , Greece

Site Reference ID/Investigator# 62483

Komotini, , Greece

Site Reference ID/Investigator# 62642

Komotini, , Greece

Site Reference ID/Investigator# 62575

Korydallos, , Greece

Site Reference ID/Investigator# 62631

Lamia, , Greece

Site Reference ID/Investigator# 62635

Lamia, , Greece

Site Reference ID/Investigator# 62626

Larissa, , Greece

Site Reference ID/Investigator# 62638

Larissa, , Greece

Site Reference ID/Investigator# 62628

Larissa, , Greece

Site Reference ID/Investigator# 62637

Larissa, , Greece

Site Reference ID/Investigator# 62574

Megara, , Greece

Site Reference ID/Investigator# 62630

N. Ionia Volou, , Greece

Site Reference ID/Investigator# 62397

Néa Erythraía, , Greece

Site Reference ID/Investigator# 62385

Néa Filadélfeia, , Greece

Site Reference ID/Investigator# 62399

Néa Smýrni, , Greece

Site Reference ID/Investigator# 62582

Nikaia, , Greece

Site Reference ID/Investigator# 62585

P. Faliro, , Greece

Site Reference ID/Investigator# 62393

Paianía, , Greece

Site Reference ID/Investigator# 62394

Pallini, , Greece

Site Reference ID/Investigator# 62522

Panórama, , Greece

Site Reference ID/Investigator# 62501

Pátrai, , Greece

Site Reference ID/Investigator# 62502

Pátrai, , Greece

Site Reference ID/Investigator# 62492

Pátrai, , Greece

Site Reference ID/Investigator# 62401

Peristeri, , Greece

Site Reference ID/Investigator# 62402

Peristeri, , Greece

Site Reference ID/Investigator# 62578

Peristeri, , Greece

Site Reference ID/Investigator# 62388

Peuki, , Greece

Site Reference ID/Investigator# 62396

Peuki, , Greece

Site Reference ID/Investigator# 62579

Piraeus, , Greece

Site Reference ID/Investigator# 62520

Polykastro, , Greece

Site Reference ID/Investigator# 62495

Pýrgos, , Greece

Site Reference ID/Investigator# 62496

Pýrgos, , Greece

Site Reference ID/Investigator# 62510

Rhodes, , Greece

Site Reference ID/Investigator# 62590

Rhodes, , Greece

Site Reference ID/Investigator# 62592

Rhodes, , Greece

Site Reference ID/Investigator# 62640

Sappes Komotinis, , Greece

Site Reference ID/Investigator# 62641

Serres, , Greece

Site Reference ID/Investigator# 62513

Sykiés, , Greece

Site Reference ID/Investigator# 62509

Thermi, Thessaloniki, , Greece

Site Reference ID/Investigator# 62514

Thessaloniki, , Greece

Site Reference ID/Investigator# 62517

Thessaloniki, , Greece

Site Reference ID/Investigator# 62516

Thessaloniki, , Greece

Site Reference ID/Investigator# 62521

Thessaloniki, , Greece

Site Reference ID/Investigator# 62523

Thessaloniki, , Greece

Site Reference ID/Investigator# 62506

Véria, , Greece

Site Reference ID/Investigator# 62627

Volos, , Greece

Site Reference ID/Investigator# 62634

Volos, , Greece

Site Reference ID/Investigator# 62486

Vraxnaiika, , Greece

Site Reference ID/Investigator# 62387

Výronas, , Greece

Site Reference ID/Investigator# 62485

Xánthi, , Greece

Site Reference ID/Investigator# 62488

Xánthi, , Greece

Countries

Greece

Other Identifiers

P13-165

Identifier Type: -

Identifier Source: org_study_id