Clinical trial NCT01562613: A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan
Official title: Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Stroke
Keywords: Stroke
Hypertension
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with eprosartan according to routine medical practice from hospitals and private physicians.

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)

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)

Primary outcomes:
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.
timeFrame: Baseline up to 6 months
measure: The Absolute Change in Systolic Blood Pressure From Baseline
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Change in Framingham Stroke Risk Profile Scores of the Participating Patients
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Agrinio
country: Greece
facility: Site Reference ID/Investigator# 62499
city: Agrinio
country: Greece
facility: Site Reference ID/Investigator# 62500
city: Alimos
country: Greece
facility: Site Reference ID/Investigator# 62577
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 62386
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 62398
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 62389
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 62384
city: Chalandri
country: Greece
facility: Site Reference ID/Investigator# 62392
city: Chalandri
country: Greece
facility: Site Reference ID/Investigator# 62395
city: Chalandri
country: Greece
facility: Site Reference ID/Investigator# 62391
city: Chalkida
country: Greece
facility: Site Reference ID/Investigator# 62633
city: Chalkida
country: Greece
facility: Site Reference ID/Investigator# 62629
city: Chania
country: Greece
facility: Site Reference ID/Investigator# 62507
city: Chania
country: Greece
facility: Site Reference ID/Investigator# 62508
city: Chania
country: Greece
facility: Site Reference ID/Investigator# 62511
city: Chania
country: Greece
facility: Site Reference ID/Investigator# 62588
city: Drama
country: Greece
facility: Site Reference ID/Investigator# 62484
city: Eleftherio, Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62518
city: Euosmos, Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62512
city: Galatsi
country: Greece
facility: Site Reference ID/Investigator# 62390
city: Glyfada
country: Greece
facility: Site Reference ID/Investigator# 62584
city: Glyfada
country: Greece
facility: Site Reference ID/Investigator# 62586
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 62589
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 62591
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 62505
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 62593
city: Heraklion
country: Greece
facility: Site Reference ID/Investigator# 62587
city: Ioannina
country: Greece
facility: Site Reference ID/Investigator# 62503
city: Ioannina
country: Greece
facility: Site Reference ID/Investigator# 62497
city: Ioannina
country: Greece
facility: Site Reference ID/Investigator# 62493
city: Kalamata
country: Greece
facility: Site Reference ID/Investigator# 62487
city: Kallithea
country: Greece
facility: Site Reference ID/Investigator# 62580
city: Kavala
country: Greece
facility: Site Reference ID/Investigator# 62645
city: Kavala
country: Greece
facility: Site Reference ID/Investigator# 62644
city: Komotini
country: Greece
facility: Site Reference ID/Investigator# 62483
city: Komotini
country: Greece
facility: Site Reference ID/Investigator# 62642
city: Korydallos
country: Greece
facility: Site Reference ID/Investigator# 62575
city: Lamia
country: Greece
facility: Site Reference ID/Investigator# 62631
city: Lamia
country: Greece
facility: Site Reference ID/Investigator# 62635
city: Larisa
country: Greece
facility: Site Reference ID/Investigator# 62626
city: Larisa
country: Greece
facility: Site Reference ID/Investigator# 62638
city: Larisa
country: Greece
facility: Site Reference ID/Investigator# 62628
city: Larisa
country: Greece
facility: Site Reference ID/Investigator# 62637
city: Megara
country: Greece
facility: Site Reference ID/Investigator# 62574
city: N. Ionia Volou
country: Greece
facility: Site Reference ID/Investigator# 62630
city: Nea Erythraia
country: Greece
facility: Site Reference ID/Investigator# 62397
city: Nea Filadelfeia
country: Greece
facility: Site Reference ID/Investigator# 62385
city: Nea Smyrni
country: Greece
facility: Site Reference ID/Investigator# 62399
city: Nikaia
country: Greece
facility: Site Reference ID/Investigator# 62582
city: P. Faliro
country: Greece
facility: Site Reference ID/Investigator# 62585
city: Paiania
country: Greece
facility: Site Reference ID/Investigator# 62393
city: Pallini
country: Greece
facility: Site Reference ID/Investigator# 62394
city: Panorama
country: Greece
facility: Site Reference ID/Investigator# 62522
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 62501
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 62502
city: Patras
country: Greece
facility: Site Reference ID/Investigator# 62492
city: Peiraias
country: Greece
facility: Site Reference ID/Investigator# 62579
city: Peristeri
country: Greece
facility: Site Reference ID/Investigator# 62401
city: Peristeri
country: Greece
facility: Site Reference ID/Investigator# 62402
city: Peristeri
country: Greece
facility: Site Reference ID/Investigator# 62578
city: Peuki
country: Greece
facility: Site Reference ID/Investigator# 62388
city: Peuki
country: Greece
facility: Site Reference ID/Investigator# 62396
city: Polykastro
country: Greece
facility: Site Reference ID/Investigator# 62520
city: Pyrgos
country: Greece
facility: Site Reference ID/Investigator# 62495
city: Pyrgos
country: Greece
facility: Site Reference ID/Investigator# 62496
city: Rodes
country: Greece
facility: Site Reference ID/Investigator# 62510
city: Rodes
country: Greece
facility: Site Reference ID/Investigator# 62590
city: Rodes
country: Greece
facility: Site Reference ID/Investigator# 62592
city: Sappes Komotinis
country: Greece
facility: Site Reference ID/Investigator# 62640
city: Serres
country: Greece
facility: Site Reference ID/Investigator# 62641
city: Sykies
country: Greece
facility: Site Reference ID/Investigator# 62513
city: Thermi, Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62509
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62514
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62517
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62516
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62521
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 62523
city: Veria
country: Greece
facility: Site Reference ID/Investigator# 62506
city: Volos
country: Greece
facility: Site Reference ID/Investigator# 62627
city: Volos
country: Greece
facility: Site Reference ID/Investigator# 62634
city: Vraxnaiika
country: Greece
facility: Site Reference ID/Investigator# 62486
city: Vyronas
country: Greece
facility: Site Reference ID/Investigator# 62387
city: Xanthi
country: Greece
facility: Site Reference ID/Investigator# 62485
city: Xanthi
country: Greece
facility: Site Reference ID/Investigator# 62488
Study officials:
affiliation: Abbott
name: Maria Daskalaki, MD
role: STUDY_DIRECTOR
References: