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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01562613
First received: March 16, 2012
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition
Hypertension
Stroke

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 absolute change in systolic Blood Pressure from baseline [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    The absolute change in systolic Blood Pressure from baseline


Secondary Outcome Measures:
  • The Framingham stroke risk profile scores of the participating patients [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
    The Framingham stroke risk profile scores of the participating patients


Enrollment: 533
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypertensive patients
All eligible hypertensive patients treated with eprosartan

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Adult patients (age greater or equal to 18 years)
  2. Hypertensive patients, with a sitting Systolic Blood Pressure above 140mmHg or 130mmHg 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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562613

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01562613     History of Changes
Other Study ID Numbers: P13-165
Study First Received: March 16, 2012
Last Updated: April 12, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Abbott:
Stroke
Hypertension

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Eprosartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014