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

NCT02024100 | Completed DMC

• 1 other identifier: HD_EPR_OS2013
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• To assess the changes of pulse pressure at 12 weeks

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

  12 weeks

Secondary Outcomes (1)

• - 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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General hospitals

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chang Hwan Yoon, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: December 31, 2013
• Study Start: February 6, 2014
• Primary Completion: December 26, 2016
• Study Completion: December 26, 2016
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

KR (1)