Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

NCT04120753 | Completed Phase 4

• 1 other identifier: DWJ1351_P401
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• mLDL-C change rate (%)

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

  8 weeks

• mLDL-C change rate

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

  8 weeks

Secondary Outcomes (14)

• Change rate (%) in mLDL-C

  4 weeks

• cLDL-C* change rate

  4 weeks

• cLDL-C* change rate

  8 weeks

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

  4 weeks

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

  8 weeks

Study Arms (3)

Treatment 1

EXPERIMENTAL

OLOMAX 20/5/5mg

Drug: OLOMAX 20/5/5mg

Treatment 2

EXPERIMENTAL

OLOMAX 20/5/10mg

Drug: OLOMAX 20/5/10mg

Treatment 3

ACTIVE COMPARATOR

Olmesartan 20 mg/Amlodipine 5 mg

Drug: Olmesartan 20 mg/Amlodipine 5 mg

Interventions

OLOMAX 20/5/5mg DRUG

Tablets, Oral, QD

Also known as: Olomax Tablet

Treatment 1

OLOMAX 20/5/10mg DRUG

Tablets, Oral, QD

Also known as: Olomax Tablet

Treatment 2

Olmesartan 20 mg/Amlodipine 5 mg DRUG

Tablets, Oral, QD

Also known as: Sevikar HCT

Treatment 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \- 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Daewoong pharmatceutical

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37814541 DERIVED

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

olmesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Inho Chae

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: August 26, 2019
• Primary Completion: July 6, 2021
• Study Completion: July 6, 2021
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

KR (1)