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Completed

NCT Number: NCT05184179

Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab

Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).

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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

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

About this study

The study will start after investigator determines the administration of Olomax tablets based on the investigator's judgement and obtaining informed consent from the subject during subject's daily visit.

The dose of the Olomax tablet for each subject will be determined based on efficacy and drug resistance according to the subject's previous drug administration.

Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).

Efficacy of Olomax tablets will be evaluated based on the data collected from more than 24 weeks to 48 weeks(+8 weeks) from the baseline visit. Safety of Olomax tablets will be evaluated based on the adverse events collected during the study peroid.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults over the age of 19
  • Patients eligible for Olomax Tab. prescription in accordance with the approved product manual in Korea
  • Patients who are determined to prescribe Olomax Tab. at the discretion of the investigators.
  • Antihypertensive agent: Do not include more than 3 agents.
  • Anti-abnormal lipidemia: Do not include more than 2 agents.
  • Subjects who are already administered beta blocker (BB) or diuretics due to other diseases such as angina, not for the purpose of treating hypertension may be included.
  • Consent on the use of information by the patient

Exclusion criteria

  • Patients who have already administered olomax tablets.
  • Subject who fall under ' Do not administer to the following patients' in the precautions for use
  • A patient who does not meet the inclusion/exclusion criteria participates
  • The patient withdraws consent for the study
  • The administration of the study drug is discontinued
  • It is impossible to follow up during the observation period
  • The investigator determines that it is no longer feasible to continue the study

Treatment and study plan

olmesartan medoxomil

Drug

Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca

Other names: Amoldipine Besylate, Rosuvastatin Ca

Primary outcomes

  1. Blood pressure treatment goal achievement rate

    Time frame: more than 24 weeks

    Blood pressure treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose blood pressure reached the target value

  2. LDL-C treatment goal achievement rate

    Time frame: more than 24 weeks

    LDL-C treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose LDL-C reached the target level

Secondary outcomes

  1. Change in blood pressure

    Time frame: 24 to 48 weeks

    Change in blood pressure at 24 to 48 weeks compared to baseline

  2. The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal

    Time frame: 24 to 48 weeks

    The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal at 24 to 48 weeks

  3. the percentage of patients maintaining the treatment goal and the amount of change in blood pressure

    Time frame: 24 to 48 weeks

    Among patients who reached the treatment goal at baseline, the percentage of patients maintaining the treatment goal and the amount of change in blood pressure at 24 to 48 weeks for each antihypertensive drug (single, double drug combination classification)

  4. Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal

    Time frame: 24 to 48 weeks

    Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal at 24 to 48 weeks

  5. For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal

    Time frame: 24 to 48 weeks

    For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal at 24 to 48 weeks by antihypertensive drug (single, combined classification)

  6. Change in LDL-C

    Time frame: 24 to 48 weeks

    Change in LDL-C at 24 to 48 weeks compared to baseline

  7. Among patients who reached the treatment goal at baseline, the change in LDL-C, the proportion of patients maintaining the treatment goal

    Time frame: 24 to 48 weeks

    Among patients who reached the treatment goal at baseline, the change in LDL-C at 24 to 48 weeks and the proportion of patients maintaining the treatment goal

  8. Among patients who reached the treatment goal at baseline, the change in LDL-C , the proportion of eligible patients maintaining the treatment goal

    Time frame: 24 to 48 weeks

    Among patients who reached the treatment goal at baseline, the change in LDL-C at 24 to 48 weeks for each anti-dyslipidemia agent and the proportion of eligible patients maintaining the treatment goal

  9. For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal

    Time frame: 24 to 48 weeks

    For patients who did not reach the treatment goal at baseline, change in LDL-C and rate of reaching the treatment goal at 24 to 48 weeks

  10. For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal

    Time frame: 24 to 48 weeks

    For patients who did not reach the treatment goal at baseline, change in LDL-C and rate of reaching the treatment goal at 24 to 48 weeks for each anti-dyslipidemia agent

  11. Change amount and rate of change in lipid variables

    Time frame: 24 to 48 weeks

    Change amount and rate of change in lipid variables (Non-HDL, HDL-C, TG, TC) at 24 to 48 weeks compared to the baseline

  12. the rate and amount of change in both blood pressure and LDL-C

    Time frame: more than 24 weeks

    Patients who underwent FU for more than 24 weeks compared to the baseline, the rate and amount of change in both blood pressure and LDL-C reached the target values

  13. Change in Framingham Risk Score (FRS)

    Time frame: more than 24 weeks

    Change in Framingham Risk Score (FRS) over 24 weeks compared to baseline

  14. change in carotid intima-media thickening (CIMT) value

    Time frame: more than 24 weeks

    If data exists, change in carotid intima-media thickening (CIMT) value over 24 weeks compared to baseline

  15. hsCRP change

    Time frame: more than 24 weeks

    If information is collected, hsCRP change over 24 weeks compared to baseline

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab. for Patients With Hypertension and Dyslipidemia

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Jul 1, 2024

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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