N/A
N=533
A Blood Pressure Regulation and Stroke Risk Evaluation Study in Hypertensive Patients Treated With Eprosartan
Hypertension · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01562613 ↗Enrolled (actual)
533
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: 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. — 62.8 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
62.8 | — |
| PRIMARY The Absolute Change in Systolic Blood Pressure From Baseline |
-31.1 | — |
| SECONDARY Change in Framingham Stroke Risk Profile Scores of the Participating Patients |
14; 11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult patients (age greater or equal to 18 years)
- 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
- Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice
- 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
- Any contraindication to eprosartan or the excipients (according to the local label)
Data sourced from ClinicalTrials.gov (NCT01562613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.