HypertensionNCT02024100
Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure (Teveten_MS)
An observational study of Hypertension, run by Handok Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- How many people
- 109 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Feb 2014to 26 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General hospitals
Who may be able to join
- 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
Who cannot join
- Patients who is administered with 3 or more than 3 antihypertensive drugs
- Patients who is contraindicated with Eprosartan by the product label
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, 463-717
About this study
Official title: Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure in Hypertensive Patients With Metabolic Syndrome
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.
Read the 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)
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study start6 Feb 2014
- Primary completion26 Dec 2016
- Study completion26 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang Hwan Yoon, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024100
- Sponsor's protocol ID
- HD_EPR_OS2013
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2013
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure in Hypertensive Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02024100
- Acronym / sponsor ID
- HD_EPR_OS2013
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 26 Dec 2016 (actual)
- Study completion
- 26 Dec 2016 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General hospitals
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who is administered with 3 or more than 3 antihypertensive drugs
- Patients who is contraindicated with Eprosartan by the product label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Hwan Yoon, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Handok Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the changes of pulse pressure at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.