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

Sponsor
Handok Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02024100
Collaborator
(none)
240
Enrollment
1
Location
36
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Time Perspective:
    Prospective
    Official Title:
    Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure in Hypertensive Patients With Metabolic Syndrome
    Study Start Date :
    Dec 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Bundang-gu Korea, Republic of 463-717

    Sponsors and Collaborators

    • Handok Inc.

    Investigators

    • Principal Investigator: Chang Hwan Yoon, MD, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Handok Inc.
    ClinicalTrials.gov Identifier:
    NCT02024100
    Other Study ID Numbers:
    • HD_EPR_OS2013
    First Posted:
    Dec 31, 2013
    Last Update Posted:
    Jan 5, 2016
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Jan 5, 2016