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Active, Not Recruiting

NCT Number: NCT05411887

Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab

The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hyperlipidemias Cardiovascular Diseases Dyslipidemias Hypertension 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

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • men and women over the age of 19
  • Patients who signed a written consent form to participate in the study
  • Patients who are eligible for Olostar tablet prescription according to domestic permission

Exclusion criteria

  • A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual
  • Patients in hospital (hospitals only; nursing care facilities can be recruited)
  • A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract

Treatment and study plan

Rosuvastatin, Olmesartan Medoxomil

Drug

Olostar Tablet

Primary outcomes

  1. absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)

    Time frame: 24 weeks

    Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline

  2. absolute change and rate of change in systolic and diastolic blood pressure

    Time frame: 24 weeks

    Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline

Secondary outcomes

  1. Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals

    Time frame: 24 weeks

    Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals assessed 6 months after administration of Olosta tablets

  2. LDL-C treatment goal achievement rate

    Time frame: 24 weeks

    LDL-C treatment goal achievement rate at 24 weeks

  3. Blood pressure treatment goal achievement rate

    Time frame: 24 weeks

    Blood pressure treatment goal achievement rate at 24 weeks

  4. Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg

    Time frame: 24 weeks

    Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg at 24 weeks

  5. Olostar tablet compliance

    Time frame: 24 weeks

    Olostar tablet compliance at 24 weeks

  6. Olostar tablet dose change

    Time frame: 24 weeks

    Olostar tablet dose change: ① Proportion of subjects by initial dose, ② Average number of dose changes, ③ Proportion of subjects by dose at the end at 24 weeks

  7. Olostar Tablet persistence

    Time frame: 24 weeks

    Olostar Tablet persistence: ① persistence rate; ② Median time to discontinuation; ③ Evaluation of reasons for suspension

  8. Evaluation of compliance

    Time frame: 24 weeks

    Evaluation of compliance with therapeutic lifestyle improvement (eating habits and amount of exercise)

  9. Assessment of Variables Influencing the Simultaneous Achievement of General

    Time frame: 24 weeks

    Assessment of Variables Influencing the Simultaneous Achievement of General Treatment Goals for Hypertension and Low-Density Lipoprotein Cholesterol (LDL-C) Treatment Goals and the Creation of a Predictive Model at 24 weeks

  10. Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.)

    Time frame: 24 weeks

    Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) at 24 weeks

  11. Evaluation of variables affecting compliance and persistence with Olostar tablets

    Time frame: 24 weeks

    Evaluation of variables affecting compliance and persistence with Olostar tablets at 24 weeks

  12. Evaluation of convenience of taking Olostar tablets

    Time frame: 24 weeks

    Evaluation of convenience of taking Olostar tablets at 24 weeks

  13. Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets

    Time frame: 24 weeks

    Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets at 24 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2022
Registry last updated
Aug 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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