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
  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 (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


Secondary Outcome Measures:
  • 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.



Enrollment: 533
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 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 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)

  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

  Show 84 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Maria Daskalaki, MD Abbott
  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
Results First Received: March 27, 2014
Last Updated: August 8, 2014
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

ClinicalTrials.gov processed this record on September 30, 2014