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

Stroke Clinical Trial

Official title:

Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562613
• Other study ID #: P13-165
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: August 8, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2014
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 533
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Stroke

Locations

Country	Name	City	State
Greece	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# 62384	Athens
Greece	Site Reference ID/Investigator# 62386	Athens
Greece	Site Reference ID/Investigator# 62389	Athens
Greece	Site Reference ID/Investigator# 62398	Athens
Greece	Site Reference ID/Investigator# 62391	Chalandri
Greece	Site Reference ID/Investigator# 62392	Chalandri
Greece	Site Reference ID/Investigator# 62395	Chalandri
Greece	Site Reference ID/Investigator# 62629	Chalkida
Greece	Site Reference ID/Investigator# 62633	Chalkida
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# 62505	Heraklion
Greece	Site Reference ID/Investigator# 62587	Heraklion
Greece	Site Reference ID/Investigator# 62589	Heraklion
Greece	Site Reference ID/Investigator# 62591	Heraklion
Greece	Site Reference ID/Investigator# 62593	Heraklion
Greece	Site Reference ID/Investigator# 62493	Ioannina
Greece	Site Reference ID/Investigator# 62497	Ioannina
Greece	Site Reference ID/Investigator# 62503	Ioannina
Greece	Site Reference ID/Investigator# 62487	Kalamata
Greece	Site Reference ID/Investigator# 62580	Kallithea
Greece	Site Reference ID/Investigator# 62644	Kavala
Greece	Site Reference ID/Investigator# 62645	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	Larisa
Greece	Site Reference ID/Investigator# 62628	Larisa
Greece	Site Reference ID/Investigator# 62637	Larisa
Greece	Site Reference ID/Investigator# 62638	Larisa
Greece	Site Reference ID/Investigator# 62574	Megara
Greece	Site Reference ID/Investigator# 62630	N. Ionia Volou
Greece	Site Reference ID/Investigator# 62397	Nea Erythraia
Greece	Site Reference ID/Investigator# 62385	Nea Filadelfeia
Greece	Site Reference ID/Investigator# 62399	Nea Smyrni
Greece	Site Reference ID/Investigator# 62582	Nikaia
Greece	Site Reference ID/Investigator# 62585	P. Faliro
Greece	Site Reference ID/Investigator# 62393	Paiania
Greece	Site Reference ID/Investigator# 62394	Pallini
Greece	Site Reference ID/Investigator# 62522	Panorama
Greece	Site Reference ID/Investigator# 62492	Patras
Greece	Site Reference ID/Investigator# 62501	Patras
Greece	Site Reference ID/Investigator# 62502	Patras
Greece	Site Reference ID/Investigator# 62579	Peiraias
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# 62520	Polykastro
Greece	Site Reference ID/Investigator# 62495	Pyrgos
Greece	Site Reference ID/Investigator# 62496	Pyrgos
Greece	Site Reference ID/Investigator# 62510	Rodes
Greece	Site Reference ID/Investigator# 62590	Rodes
Greece	Site Reference ID/Investigator# 62592	Rodes
Greece	Site Reference ID/Investigator# 62640	Sappes Komotinis
Greece	Site Reference ID/Investigator# 62641	Serres
Greece	Site Reference ID/Investigator# 62513	Sykies
Greece	Site Reference ID/Investigator# 62509	Thermi, Thessaloniki
Greece	Site Reference ID/Investigator# 62514	Thessaloniki
Greece	Site Reference ID/Investigator# 62516	Thessaloniki
Greece	Site Reference ID/Investigator# 62517	Thessaloniki
Greece	Site Reference ID/Investigator# 62521	Thessaloniki
Greece	Site Reference ID/Investigator# 62523	Thessaloniki
Greece	Site Reference ID/Investigator# 62506	Veria
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	Vyronas
Greece	Site Reference ID/Investigator# 62485	Xanthi
Greece	Site Reference ID/Investigator# 62488	Xanthi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	The Absolute Change in Systolic Blood Pressure From Baseline	The absolute change in systolic Blood Pressure from baseline	Baseline up to 6 months	No
Secondary	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.	Baseline up to 6 months	No