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HypertensionPhase 4NCT04120753

Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

A Phase 4 study testing OLOMAX 20/5/5mg, OLOMAX 20/5/10mg and Olmesartan 20 mg/Amlodipine 5 mg in people with Hypertension and Dyslipidemias, 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

The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension, Dyslipidemias
What is being tested?
OLOMAX 20/5/5mg, OLOMAX 20/5/10mg and Olmesartan 20 mg/Amlodipine 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteSouth Korea
Study dates
26 Aug 2019to 6 Jul 2021
Phase
Phase 4
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

Who may be able to join

  • Screening (Visit 1) Inclusion Criteria
  • Men and women over 19 years of age as of the date of written consent
  • High blood pressure patients who meet the following criteria - In case of new arrivals, Sitting systolic blood pressure (sitSBP) ≥ 160 mmHg or sitting diastolic blood pressure (sitDBP) ≥ 100 mmHg, or
  • If you are taking one antihypertensive drug from the Angiotensin II Receptor Blocker (ARB) or Calcium-Channel Blocker (CCB) class, sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg, or
  • If you are taking ARB and CCB class antihypertensive drugs together
  • Those who meet the following mLDL-C criteria* (*Korean Society of Lipid and Atherosclerosis Dyslipidemia Treatment Guideline 3)
Show all 17Show fewer
  • For cardiovascular disease low risk group #1, LDL-C ≥ 130 mg/dL or
  • For intermediate risk group #2 for cardiovascular disease, LDL-C ≥ 100 mg/dL. #1: Low-risk group: Those who do not have the following major cardiovascular risk factors other than high blood pressure
  • #2: Moderate risk group: People with one or more of the following major cardiovascular risk factors other than hypertension
  • Age (men ≥45 years, women ≥55 years)
  • Family history of early onset coronary artery disease (coronary artery disease occurs in family members [parents, siblings] <55 years old for men and <65 years old for women)
  • Smoking
  • High density lipoprotein-cholesterol (HDL-C) <40 mg/dL (However, in case of HDL-C ≥60 mg/dL, 1 is subtracted from the number of major risk factors.)
  • Those who voluntarily agree to participate in clinical trials and sign a written consent form
  • Random allocation (visit 2) Inclusion criteria
  • Those who have medication compliance of more than 70% during the introduction period of Sevica Tablet 5/20 mg and have good TLC performance according to the investigator's judgment
  • Those who meet the following test values for each institution at the time of the baseline (visit 2) visit ① For low-risk cardiovascular disease group, mLDL-C ≥ 130 mg/dL or For those at moderate risk for cardiovascular disease, mLDL-C ≥ 100 mg/dL

Who cannot join

  • Patient with hypersensitivity Olmesartan, Amlodipine, Rosuvastatin, dihydropyridine
  • Who disagreed to perform effective contraception during the clinical trial
  • Orthostatic hypotension with symptoms
  • Secondary hypertension and suspected secondary hypertension
  • Creatinine clearance < 30mL/min
  • AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range)
Show all 24Show fewer
  • Patients with hypersensitivity to the main ingredient (Olmesartan, Amlodipine or Rosuvastatin) or components of the investigational drug or dihydropyridine derivatives
  • Pregnant and lactating women, women and men of childbearing potential who do not agree to use appropriate contraception during the clinical trial period
  • Implantation of an intrauterine device or intrauterine system, ② Double barrier method for men or women of childbearing potential (condoms and contraceptive diaphragms, vaginal sponges or cervical caps), ③ Sterilization procedures (vasectomy, bilateral tubal ligation, etc.)
  • Patients with symptomatic orthostatic hypotension
  • Patients with secondary hypertension or patients suspected of having secondary hypertension (e.g. aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)
  • Those with confirmed medical history, concomitant diseases, or surgical history/procedure history:
  • ① The following cardiovascular disease occurred within 24 weeks from the time of screening
  • Coronary artery disease, atherosclerotic ischemic stroke and transient cerebral ischemic attack, peripheral artery disease, carotid artery disease (limited to cases where significant carotid artery stenosis is confirmed), abdominal aneurysm, severe aortic stenosis, coronary artery revascularization (PTCA or CABG) , Arrhythmias requiring treatment (ventricular tachycardia, etc.)
  • Myopathy, including rhabdomyolysis, that occurred within 24 weeks from the time of screening
  • ③ Biliary obstruction occurring within 24 weeks from the time of screening
  • Severe liver failure that occurred within 24 weeks from the time of screening ⑤ Drug or alcohol abuse within 1 year from the time of screening ⑥ Major mental illness (depression, bipolar disorder, etc.) ⑦ Malignant tumor within 5 years from the time of screening 6) Persons confirmed to have abnormalities in the following laboratory tests at the time of screening and randomization ① CK ≥ 2
  • Triglyceride (TG) ≥ 500 mg/dL ③ Active liver disease including persistent ALT elevation of unknown cause or AST ≥ 3 ④ The following renal function abnormalities:
  • Kidney dialysis or
  • Patients with severe renal impairment (creatinine clearance (CLcr) < 30 mL/min)
  • Hyperkalemia (K >5.5 mEq/L)
  • Hyponatremia (Na <135 mEq/L) or uncorrected sodium depletion ⑦ Hyperuricemia (Uric acid >10 mg/dL) 7) Those who have taken statin drugs or non-statin lipid regulators within 8 weeks before screening 8) Those expected to be administered the following drugs during the clinical trial period, including screening
  • Aliskiren ② Cyclosporine ③ Statin preparations other than clinical investigational drugs ④ Vistatin lipid regulators other than clinical investigational drugs
  • Antihypertensive drugs other than clinical investigational drugs ⑥ Other drugs that may affect blood lipids 9) People with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 10) A person who has received another investigational drug or a clinical trial medical device within 30 days before screening 11) Other people deemed unsuitable for participation in clinical trials according to the judgment of the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Daewoong pharmatceutical

    Seoul

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab in Hypertension Patients With Low-Intermediate Risk for Cardiovascular Disease

The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.

Read the detailed description

The patients who meet the inclusion/exclusion criteria will be randomized 1:1:1 to test group 1 (olomax tablet 20/5/5mg), test group 2 (olomax tablet 20/5/10mg), and control group (sevica tablet 5/20mg.

After randomization, the drug will be administered for 8 weeks according to the assigned group.

During the administration period, subjects will conduct a total of three outpatient visits at 4 weeks (Visit 3) and 8 weeks (Visit 4, EOS), including randomized visits (Visit 2).

Being tested
OLOMAX 20/5/5mg, OLOMAX 20/5/10mg, Olmesartan 20 mg/Amlodipine 5 mg
Medical subject headings
Hypertension, Dyslipidemias

What participants receive

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

  • OLOMAX 20/5/5mgDrug

    Also called Olomax Tablet

    Tablets, Oral, QD

  • OLOMAX 20/5/10mgDrug

    Also called Olomax Tablet

    Tablets, Oral, QD

  • Olmesartan 20 mg/Amlodipine 5 mgDrug

    Also called Sevikar HCT

    Tablets, Oral, QD

Study groups in NCT04120753
Study groupRoleWhat they receive
Treatment 1ExperimentalOLOMAX 20/5/5mg
Receives: Drug: OLOMAX 20/5/5mg
Treatment 2ExperimentalOLOMAX 20/5/10mg
Receives: Drug: OLOMAX 20/5/10mg
Treatment 3Active comparatorOlmesartan 20 mg/Amlodipine 5 mg
Receives: Drug: Olmesartan 20 mg/Amlodipine 5 mg

What is being measured

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

  1. mLDL-C change rate (%)

    mLDL-C change rate (%) at 8 weeks after administration compared to baseline in test group 1 and control group

    Measured: 8 weeks

  2. mLDL-C change rate

    mLDL-C change rate (%) at 8 weeks after administration compared to baseline in test group 2 and control group

    Measured: 8 weeks

Secondary outcomes (14)

  1. Change rate (%) in mLDL-C

    Change rate (%) in mLDL-C at 4 weeks of administration of investigational drug compared to baseline

    Measured: 4 weeks

  2. cLDL-C* change rate

    cLDL-C* change rate (%) at 4 weeks of administration of investigational drug compared to baseline

    Measured: 4 weeks

  3. cLDL-C* change rate

    cLDL-C* change rate (%) at 8 weeks of administration of investigational drug compared to baseline

    Measured: 8 weeks

  4. Change amount and rate of change (%) in each of the following lipid indicators

    Change amount and rate of change (%) in each of the following lipid indicators at 4 weeks of administration of the investigational drug compared to the baseline

    Measured: 4 weeks

  5. Change amount and rate of change (%) in each of the following lipid indicators

    Change amount and rate of change (%) in each of the following lipid indicators at 8 weeks of administration of the investigational drug compared to the baseline

    Measured: 8 weeks

  6. Proportion of test subjects with mLDL-C less than 70 mg/dL

    Proportion of test subjects with mLDL-C less than 70 mg/dL at 4 weeks of administration of investigational drug (%)

    Measured: 4 weeks

  7. Proportion of test subjects with mLDL-C less than 70 mg/dL

    Proportion of test subjects with mLDL-C less than 70 mg/dL at 8 weeks of administration of investigational drug (%)

    Measured: 8 weeks

  8. Proportion of test subjects with mLDL-C less than 100 mg/dL

    Proportion of test subjects with mLDL-C less than 100 mg/dL at 4 weeks of administration of investigational drug (%)

    Measured: 4 weeks

  9. Proportion of test subjects with mLDL-C less than 100 mg/dL

    Proportion of test subjects with mLDL-C less than 100 mg/dL at 8 weeks of administration of investigational drug (%)

    Measured: 8 weeks

  10. Change and rate of change in sitSBP (%)

    Change and rate of change in sitSBP (%) at 4 weeks of administration of investigational drug compared to baseline

    Measured: 4 weeks

  11. Change and rate of change in sitDBP (%)

    Change and rate of change in sitDBP (%) at 8 weeks of administration of investigational drug compared to baseline

    Measured: 8 weeks

  12. Blood pressure normalization* rate (%

    Blood pressure normalization* rate (%) at 8 weeks after administration of investigational drug

    Measured: 8 weeks

  13. Change amount and rate of change (%)

    Change amount and rate of change (%) in each of the following sugar indicators at 4 weeks of administration of the investigational drug compared to the baseline

    Measured: 4 weeks

  14. Change amount and rate of change (%)

    Change amount and rate of change (%) in each of the following sugar indicators at 8 weeks of administration of the investigational drug compared to the baseline

    Measured: 8 weeks

Timeline

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

  1. First posted9 Oct 2019
  2. Study start26 Aug 2019
  3. Primary completion6 Jul 2021
  4. Study completion6 Jul 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04120753
Sponsor's protocol ID
DWJ1351_P401
Status last verified
Jun 2024
First submitted
8 Oct 2019
Last updated
1 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim BJ, Cha KS, Cho WH, Kim EJ, Choi SH, Kim MH, Kim SH, Park JB, Park SM, Sohn IS, Ryu KH, Chae IH. Efficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231205204. doi: 10.1177/10742484231205204.

    PubMed 37814541

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OLOMAX 20/5/5mg, OLOMAX 20/5/10mg and Olmesartan 20 mg/Amlodipine 5 mg in people with Hypertension and Dyslipidemias, 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 17 inclusion and 24 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

mLDL-C change rate (%) (time frame: 8 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 NCT04120753, which also lists 1 linked publication.

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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