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

NCT01562613 | Completed Results

• 1 other identifier: P13-165
• Study Type: observational
• Target: 533
• Locations: 1 country
• Sites: 84

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.

Conditions

Hypertension; Stroke

Keywords

Stroke; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in Framingham Stroke Risk Profile Scores of the Participating Patients

  Baseline up to 6 months

Study Arms (1)

Hypertensive patients

All eligible hypertensive patients treated with eprosartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Abbott: lead

Study Sites (84)

Site Reference ID/Investigator# 62499

Agrinio, 30100, Greece

Location

Site Reference ID/Investigator# 62500

Agrinio, 30100, Greece

Location

Site Reference ID/Investigator# 62577

Alimos, 17456, Greece

Location

Site Reference ID/Investigator# 62386

Athens, 10552, Greece

Location

Site Reference ID/Investigator# 62398

Athens, 11143, Greece

Location

Site Reference ID/Investigator# 62389

Athens, 11251, Greece

Location

Site Reference ID/Investigator# 62384

Athens, 11521, Greece

Location

Site Reference ID/Investigator# 62392

Chalandri, 15234, Greece

Location

Site Reference ID/Investigator# 62395

Chalandri, 15234, Greece

Location

Site Reference ID/Investigator# 62391

Chalandri, 34100, Greece

Location

Site Reference ID/Investigator# 62633

Chalcis, 15236, Greece

Location

Site Reference ID/Investigator# 62629

Chalcis, 34100, Greece

Location

Site Reference ID/Investigator# 62507

Chania, 73132, Greece

Location

Site Reference ID/Investigator# 62508

Chania, 73132, Greece

Location

Site Reference ID/Investigator# 62511

Chania, 73132, Greece

Location

Site Reference ID/Investigator# 62588

Chania, 73134, Greece

Location

Site Reference ID/Investigator# 62484

Drama, 66100, Greece

Location

Site Reference ID/Investigator# 62518

Eleftherio, Thessaloniki, 56334, Greece

Location

Site Reference ID/Investigator# 62512

Euosmos, Thessaloniki, 56224, Greece

Location

Site Reference ID/Investigator# 62390

Galatsi, 11147, Greece

Location

Site Reference ID/Investigator# 62584

Glyfada, 16561, Greece

Location

Site Reference ID/Investigator# 62586

Glyfada, 16561, Greece

Location

Site Reference ID/Investigator# 62589

Heraklion, 18536, Greece

Location

Site Reference ID/Investigator# 62591

Heraklion, 71305, Greece

Location

Site Reference ID/Investigator# 62505

Heraklion, 71307, Greece

Location

Site Reference ID/Investigator# 62593

Heraklion, 71307, Greece

Location

Site Reference ID/Investigator# 62587

Heraklion, 71409, Greece

Location

Site Reference ID/Investigator# 62503

Ioannina, 45221, Greece

Location

Site Reference ID/Investigator# 62497

Ioannina, 45332, Greece

Location

Site Reference ID/Investigator# 62493

Ioannina, 45444, Greece

Location

Site Reference ID/Investigator# 62487

Kalamata, 24100, Greece

Location

Site Reference ID/Investigator# 62580

Kallithea, 17672, Greece

Location

Site Reference ID/Investigator# 62645

Kavala, 65302, Greece

Location

Site Reference ID/Investigator# 62644

Kavala, 65403, Greece

Location

Site Reference ID/Investigator# 62483

Komotini, 67100, Greece

Location

Site Reference ID/Investigator# 62642

Komotini, 69100, Greece

Location

Site Reference ID/Investigator# 62575

Korydallos, 18120, Greece

Location

Site Reference ID/Investigator# 62631

Lamia, 35100, Greece

Location

Site Reference ID/Investigator# 62635

Lamia, 35100, Greece

Location

Site Reference ID/Investigator# 62626

Larissa, 41221, Greece

Location

Site Reference ID/Investigator# 62638

Larissa, 41221, Greece

Location

Site Reference ID/Investigator# 62628

Larissa, 41222, Greece

Location

Site Reference ID/Investigator# 62637

Larissa, 41223, Greece

Location

Site Reference ID/Investigator# 62574

Megara, 19100, Greece

Location

Site Reference ID/Investigator# 62630

N. Ionia Volou, 38446, Greece

Location

Site Reference ID/Investigator# 62397

Néa Erythraía, 14671, Greece

Location

Site Reference ID/Investigator# 62385

Néa Filadélfeia, 14671, Greece

Location

Site Reference ID/Investigator# 62399

Néa Smýrni, 17121, Greece

Location

Site Reference ID/Investigator# 62582

Nikaia, 18450, Greece

Location

Site Reference ID/Investigator# 62585

P. Faliro, 17564, Greece

Location

Site Reference ID/Investigator# 62393

Paianía, 19002, Greece

Location

Site Reference ID/Investigator# 62394

Pallini, 15351, Greece

Location

Site Reference ID/Investigator# 62522

Panórama, 55236, Greece

Location

Site Reference ID/Investigator# 62501

Pátrai, 26221, Greece

Location

Site Reference ID/Investigator# 62502

Pátrai, 26221, Greece

Location

Site Reference ID/Investigator# 62492

Pátrai, 26442, Greece

Location

Site Reference ID/Investigator# 62401

Peristeri, 12132, Greece

Location

Site Reference ID/Investigator# 62402

Peristeri, 12136, Greece

Location

Site Reference ID/Investigator# 62578

Peristeri, 12136, Greece

Location

Site Reference ID/Investigator# 62388

Peuki, 15121, Greece

Location

Site Reference ID/Investigator# 62396

Peuki, 15121, Greece

Location

Site Reference ID/Investigator# 62579

Piraeus, 18536, Greece

Location

Site Reference ID/Investigator# 62520

Polykastro, 61200, Greece

Location

Site Reference ID/Investigator# 62495

Pýrgos, 27100, Greece

Location

Site Reference ID/Investigator# 62496

Pýrgos, 27100, Greece

Location

Site Reference ID/Investigator# 62510

Rhodes, 85100, Greece

Location

Site Reference ID/Investigator# 62590

Rhodes, 85100, Greece

Location

Site Reference ID/Investigator# 62592

Rhodes, 85100, Greece

Location

Site Reference ID/Investigator# 62640

Sappes Komotinis, 69100, Greece

Location

Site Reference ID/Investigator# 62641

Serres, 62122, Greece

Location

Site Reference ID/Investigator# 62513

Sykiés, 56626, Greece

Location

Site Reference ID/Investigator# 62509

Thermi, Thessaloniki, 57001, Greece

Location

Site Reference ID/Investigator# 62514

Thessaloniki, 54022, Greece

Location

Site Reference ID/Investigator# 62517

Thessaloniki, 54623, Greece

Location

Site Reference ID/Investigator# 62516

Thessaloniki, 55132, Greece

Location

Site Reference ID/Investigator# 62521

Thessaloniki, 63077, Greece

Location

Site Reference ID/Investigator# 62523

Thessaloniki, 63200, Greece

Location

Site Reference ID/Investigator# 62506

Véria, 59100, Greece

Location

Site Reference ID/Investigator# 62627

Volos, 38221, Greece

Location

Site Reference ID/Investigator# 62634

Volos, 38221, Greece

Location

Site Reference ID/Investigator# 62486

Vraxnaiika, 25002, Greece

Location

Site Reference ID/Investigator# 62387

Výronas, 16233, Greece

Location

Site Reference ID/Investigator# 62485

Xánthi, 67100, Greece

Location

Site Reference ID/Investigator# 62488

Xánthi, 69300, Greece

Location

MeSH Terms

Conditions

Hypertension; Stroke

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Taco Baardman
• Organization: Abbott

taco.baardman@abbott.com

Study Officials

• Maria Daskalaki, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 26, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 12, 2014
• Results First Posted: July 30, 2014

Record last verified: 2014-08

Locations

GR (84)