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: August 8, 2014
Last verified: August 2014

March 16, 2012
August 8, 2014
March 2012
March 2013   (final data collection date for primary outcome 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. [ 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 (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)]

  • 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
  • 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 sytolic Blood Pressure from baseline
Complete list of historical versions of study NCT01562613 on ClinicalTrials.gov Archive Site
Change in 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 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.

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
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A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan
Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)

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.

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)
Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Hypertension
  • Stroke
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Hypertensive patients
All eligible hypertensive patients treated with eprosartan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
533
March 2013
March 2013   (final data collection date for primary outcome measure)

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01562613
P13-165
No
Abbott
Abbott
Not Provided
Study Director: Maria Daskalaki, MD Abbott
Abbott
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP