Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With Hypertension (AMPR-OS-2503)

August 20, 2026 updated by: Hanmi Pharmaceutical Company Limited

A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With Hypertension

A multicenter, prospective, non-interventional, observational study to evaluate effectiveness and safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone) in Korean patients with hypertension

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

General hospital

Description

Inclusion Criteria:

  1. Korean patients aged 19 years or older diagnosed with hypertension
  2. Individuals newly diagnosed with hypertension or currently taking a single antihypertensive drug
  3. Individuals for whom administration of Amoprel tablets has been determined based on the researcher's medical judgment
  4. Individuals who have heard an explanation of this study and have voluntarily given written consent to participate in the study

Exclusion Criteria:

  1. Individuals falling under the contraindications listed in the precautions for use of Amoprel Tab. or Amozartan Plus Tab.
  2. Pregnant women, women who may be pregnant, and nursing mothers
  3. Individuals currently participating in an interventional study
  4. Individuals deemed unsuitable for participation in this study by the researcher for other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in Systolic Blood Pressure (SBP) relative to baseline
Time Frame: the 6-month time
the 6-month time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of sequential triple combination therapy (amlodipine/losartan/chlorthalidone)
Time Frame: 2, 4, 6 months
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 2 and 4 months, and change from baseline in DBP at 6 months
2, 4, 6 months
Prescription patterns of a triple-therapy-based stepwise treatment strategy
Time Frame: 2, 4, 6 months
Proportion of Participants by Study Drug Dosage at Months 2, 4, and 6
2, 4, 6 months
safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone)
Time Frame: 2, 4 , 6 months
Incidence of Adverse Events During the 6-Month Follow-up Period
2, 4 , 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-AMPR-OS-2503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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