Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure (Teveten_MS)

The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive patients with metabolic syndrome

-Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure produced one heart beat.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, 463-717, South Korea

About this study

Primary Objective

-To assess the changes of pulse pressure at 12 weeks

Secondary Objectives

To assess the changes of pulse pressure at 4, 24 weeks
To assess the changes of systolic blood pressure and diastolic blood pressure at each visit
Percentage of responder rate* at each visit and time to get normalized BP from enrollment
Responder rate at last visit
To assess IIEF-5 (5-item Version of the International Index of Erectile Function) score at enrollment and 24 weeks (percentage of patients with ED according to IIEF-5, Changes of IIEF-5 domains)
Percentage of patients with erectile dysfunction (ED) according to IIEF-5 and changes of PP in subgroup (age 65, body mass index (BMI) 23, diabetes mellitus, dyslipidemia, benign prostate hypertrophy)
Analysis of correlation between ED and concomitant disease and concomitant medications in patients who received Eprosartan
Score changes of Framingham 10-year Coronary Heart Disease (CHD) risk at 1st visit, 4th visit
Percentages of Eprosartan monotherapy and multiple antihypertensive therapies at enrollment and last visit
Reason for treatment discontinuation (Inadequate BP control, adverse events, others)
Adverse events

Responder rate: SBP <140mmHg and DBP <90mmHg (SBP <140mmHg and DBP <85mmHg for patients with diabetes mellitus)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

20-80 years old patient at the 1st visit
Patient who is determined to prescribe Eprosartan for hypertension (patient with at least one of the following conditions) (1) Newly diagnosed hypertension (2) Inability to tolerate hypertension (for example: adverse event) (3) Lack of response to current antihypertensive medications
Metabolic syndrome patient (fulfill 3 or more components before enrollment) (1) Waist circumference (>90 for men, >80 for women) (2) Triglycerides (≥150mg/dl) (3) HDL cholesterol (<40mg/dl for men, <50mg/dl for women) (4) SBP≥130mmHg or DBP≥85mmHg or on antihypertensive medications) (5) Fasting glucose level (≥100mg/dl) or on antidiabetic medications

MS diagnosis origin: Korean diabetes association

Exclusion criteria

Patients who is administered with 3 or more than 3 antihypertensive drugs
Patients who is contraindicated with Eprosartan by the product label

Treatment and study plan

Primary outcomes

To assess the changes of pulse pressure at 12 weeks

Time frame: 12 weeks

Calculating pulse pressure at 3rd(12weeks) visit and it will be presented in descriptive statistics quantity

Secondary outcomes

- changes of pulse pressure at 4, 24 weeks - changes of blood pressure at 4, 12, 24 weeks - Duration to get normalized BP - assess IIEF-5 score - Score changes of Framingham 10-year CHD risk

Time frame: 24 weeks
- Calculating pulse pressure at each visit and it will be presented in descriptive statistics quantity
- Variation of the pulse pressure at each visit will be presented in descriptive statistics quantity and average variation's 95% confidence interval will be calculated
- Calculating systolic blood pressure and diastolic blood pressure at each visit and it will be presented in descriptive statistics quantity
- Severity of erectile dysfunction will be presented a contingency table and symmetry testing will be done whether there is a significant difference in the data
- As sub-analysis, type of study drug, age, BMI, with/without diabetes mellitus, with/without dyslipidemia, with/without benign prostate hypertrophy, type of treatment will be considered
- For safety analysis, overall incidence rate of adverse event will be presented and frequency and percentage will be presented according to body organs and preferable terminology

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure in Hypertensive Patients With Metabolic Syndrome

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Dec 31, 2013
Registry last updated: Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed