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

Handok

Status: Completed

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT02024100

HD_EPR_OS2013

Details and patient eligibility

About

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.

Full 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)

Enrollment: 109 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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