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NCT Number: NCT05450575

An Observational Study to Evaluate Effectiveness and Safety of Amosartan Q Tablet

This study was to evaluate the therapeutic effect and safety of amosartan Q tablet administration in adult patients with hypertension and dyslipidemia.

During the routine medical visit, Amosartan Q tablets were administered to patients in need of blood pressure/LDL-C control according to the investigator's judgment. In this study, effectiveness and safety information of treatment of Amosartan Q tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.

As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanmi Pharmaceutical Company Limited

Seoul, South Korea

About this study

This study was a multicenter, prospective, non-interventional, observational study of factors affecting blood pressure and blood lipids after treatment with Amosartan Q tablet in hypertension patients with dyslipidemia.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Q tablet.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with hypertension and dyslipidemia
  • Those who have already decided to administer Amosartan Q tablet under the medical judgment of the researcher
  • Those who voluntarily decided to participate in this study and consented in writing to the consent form

Exclusion criteria

  • Patients for whom use of Amosartan Q tablet is prohibited

Treatment and study plan

Amosartan Q tablet

Drug

Amlodipine, Losartan, Rosuvastatin

Other names: amosartan Q

Primary outcomes

  1. percentage(%) of patients who achieved target blood pressure

    Time frame: 6 months

  2. percentage(%) of patients who achieved target LDL-C

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Prospective, Observational Study of Factors Affecting Blood Pressure and Blood Lipids After Treatment With Amosartan Q Tablet in Hypertension Patients With Dyslipidemia

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2022
Registry last updated
Jul 8, 2022

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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