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HypertensionNCT05184179

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

An observational study of Hypertension and Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension, Dyslipidemia
What is being tested?
Olmesartan Medoxomil
How many people
5,450 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2019to 16 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The number of patients was calculated based on the analysis results of the blood pressure treatment goal achievement rate and LDL-C treatment goal acheivement rate in the Olomax Tertiary Clinical Trial. n=(〖Z_(α/2)〗^2×p(1-p))/d^2 :: Type 1 error (=0.05) p: Target Reach Rate at 24+ Weeks (=80%) d: Sampling error herefore, it means that the total number of patients required to be 95% confident that the proportion of patients whose two primary evaluation variables, blood pressure and LDL, will be included in 79-81%. Considering the dropout rate of about 20%, a total of 7,684 patients are required, so in this study, approximately 8,000 patients approximating this are finally recruited.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, Gyeonggi-do, 18450

Other trials in South Korea

About this study

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

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).

Read the detailed description

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.

Being tested
Olmesartan Medoxomil
Medical subject headings
Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olmesartan MedoxomilDrug

    Also called Amoldipine Besylate, Rosuvastatin Ca

    Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure treatment goal achievement rate

    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

    Measured: more than 24 weeks

  2. LDL-C treatment goal achievement rate

    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

    Measured: more than 24 weeks

Secondary outcomes (15)

  1. Change in blood pressure

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

    Measured: 24 to 48 weeks

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

    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

    Measured: 24 to 48 weeks

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

    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)

    Measured: 24 to 48 weeks

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

    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

    Measured: 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

    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)

    Measured: 24 to 48 weeks

  6. Change in LDL-C

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

    Measured: 24 to 48 weeks

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

    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

    Measured: 24 to 48 weeks

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

    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

    Measured: 24 to 48 weeks

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

    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

    Measured: 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

    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

    Measured: 24 to 48 weeks

  11. Change amount and rate of change in lipid variables

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

    Measured: 24 to 48 weeks

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

    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

    Measured: more than 24 weeks

  13. Change in Framingham Risk Score (FRS)

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

    Measured: more than 24 weeks

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

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

    Measured: more than 24 weeks

  15. hsCRP change

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

    Measured: more than 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start1 Dec 2019
  3. Primary completion16 Aug 2022
  4. Study completion16 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
5,450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05184179
Sponsor's protocol ID
DWJ1351_P402
Status last verified
Jun 2024
First submitted
3 Sep 2021
Last updated
1 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure treatment goal achievement rate (time frame: more than 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05184179.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.

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