Blood Pressure Control and Safety of Ex-one or Ex-one Plus in Essential Hypertension
A Multicenter, Prospective, Observational Study to Evaluate Blood Pressure Control Rates and Safety of Ex-one Tablet or Ex-one Plus Tablet in Patients With Essential Hypertension in Real-world Clinical Practice
This study aims to assess the proportion of patients with essential hypertension who achieve blood pressure control rates at Week 24 following treatment with Ex-one tablets or Ex-one Plus tablets, and to collect safety information observed during the study period.
Study Overview
Status
Conditions
Detailed Description
This study aims to evaluate the efficacy of Ex-one tablets, a two-drug fixed-dose combination of amlodipine and valsartan, or Ex-one Plus tablets, a three-drug fixed-dose combination of amlodipine, valsartan, and chlorthalidone, in patients with essential hypertension in a real-world setting, focusing on the proportion of patients who achieve blood pressure control rates. In addition, safety data will be collected and evaluated in a large patient population.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yong-an Jeong
- Phone Number: +82-31-5176-4673
- Email: yongan.jeong@inno-n.com
Study Contact Backup
- Name: Seung Kye Cho
- Phone Number: +82-31-5176-4676
- Email: seungkye.cho@inno-n.com
Study Locations
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Seoul, South Korea
- Recruiting
- HK inno.N
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Contact:
- Seung Kye Cho
- Phone Number: +82-31-5176-4676
- Email: seungkye.cho@inno-n.com
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Contact:
- Ahrong Kim
- Phone Number: +82-31-5176-4666
- Email: ahrong.kim@inno-n.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
University-affiliated hospitals and general hospitals where the study drug is administered
Description
Inclusion Criteria:
- Aged 19 years or older
- Patients for whom a decision has been made to administer the study medication for the treatment of essential hypertension in accordance with the approved prescribing information
- Patients who voluntarily provide written informed consent
Exclusion Criteria:
- Patients for whom administration of the study medication is contraindicated according to the approved prescribing information
- Patients whom the investigator considers medically unsuitable for participation in this study for reasons other than those specified above
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients achieving blood pressure control rates at Week 24 after treatment with Ex-one tablets or Ex-one Plus tablets
Time Frame: At Week 24 after enrollment
|
Blood pressure treatment target of <140/90 mmHg, according to the 2022 Guidelines for the Management of Hypertension issued by the Korean Society of Hypertension |
At Week 24 after enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IN_ANV_N01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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