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NCT Number: NCT07784296

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Gyeonggi-do, 16995, South Korea

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AMOPREL TAB 1.67/16.67/4.17mg

Drug

Follow-up of subjects prescribed medication in a non-intervention study

Primary outcomes

  1. The change in Systolic Blood Pressure (SBP) relative to baseline

    Time frame: the 6-month time

Secondary outcomes

  1. 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. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Acronym: AMPR-OS-2503

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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