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

Completed

• Conditions: Hypertension

• Registration Number: NCT02024100
• Lead Sponsor: Handok Inc.

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2013-12-26
• Study First Posted: 2013-12-31
• Study Start: 2014-02-06
• Primary Completion: 2016-12-26
• Study Completion: 2016-12-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

1. 20-80 years old patient at the 1st visit

2. 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

3. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the changes of pulse pressure at 12 weeks	12 weeks	Calculating pulse pressure at 3rd(12weeks) visit and it will be presented in descriptive statistics quantity

Secondary Outcome Measures

Name	Time	Method
- 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	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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Bundang-gu, Korea, Republic of