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NCT Number: NCT07084246

Evaluation of the Effectiveness and Safety of Rozetel Tablet in Patients After PCI: A Multi-Center Observational Study

The purpose of this study is to evaluate the effectiveness and safety of the investigational drug on blood pressure and LDL cholesterol control during the observation period in patients who have undergone percutaneous coronary intervention (PCI) in actual clinical practice.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GC Biopharma

Yongin, South Korea

About this study

This study is a multicenter, prospective, non-interventional observational study aimed at observing the efficacy and safety of the investigational product, a combination of telmisartan, rosuvastatin, and ezetimibe, in patients who have undergone percutaneous coronary intervention (PCI) for the control of blood pressure and lipid levels.

In actual clinical practice, patients aged 19 years and older who have undergone PCI and are receiving antihypertensive and dyslipidemia-related medications based on approved indications will be assessed for eligibility after receiving an explanation of the study and providing written consent, as determined by the investigator's judgment regarding the need for the investigational product.

Eligible participants according to the inclusion/exclusion criteria will receive the investigational product based on the approved indications (efficacy, dosage, precautions, etc.) after registration. Follow-up visits will be conducted at 24 weeks and 48 weeks (each ± 4 weeks) post-treatment to evaluate efficacy and safety.

All treatments, including drug administration and laboratory tests performed after the administration of the investigational product, will be conducted according to the investigator's medical judgment, independent of the participant's involvement in the study, and information to be collected in this observational study will continue for up to 48 weeks (± 4 weeks).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Adults aged 19 years and older, both male and female. 2. Patients who have undergone percutaneous coronary intervention (PCI) and are receiving antihypertensive and dyslipidemia-related medications.
  • Individuals who require the administration of the investigational product based on the investigator's medical judgment in accordance with approved indications.
  • Individuals who can understand the information provided to them and are able to voluntarily sign the informed consent form.

Exclusion criteria

  • 1. Individuals who fall under the contraindications for administration according to the approved indications of the investigational product.
  • Individuals who have a history of receiving the investigational product prior to participation in this study.
  • Individuals whom the investigator deems unsuitable for participation in this observational study for any other reason.

Treatment and study plan

Primary outcomes

  1. The proportion of participants who meet the treatment goals for BP and LDL-C

    Time frame: From enrollment to the end of treatment at 24 weeks

Sponsors and collaborators

Lead sponsor

GC Biopharma Corp

Industry

Registry information

Official study title

A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of the Rozetel Tablet in Patients Who Had Undergone Percutaneous Coronary Intervention(PCI)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

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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