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Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

Primary Purpose

Hypertension, Dyslipidemias

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OLOMAX 20/5/5mg
OLOMAX 20/5/10mg
Olmesartan 20 mg/Amlodipine 5 mg
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both man and woman who is over 19 years old
  • Patients with hypertension
  • Persons with mLDL ≥ 130mg/dL (low risk for cardiovascular disease) or mLDL ≥ 100mg/dL (intermediate risk for cardiovascular disease)
  • Written informed consent

Exclusion Criteria:

  • 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)

Sites / Locations

  • Daewoong pharmatceutical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment 1

Treatment 2

Treatment 3

Arm Description

OLOMAX 20/5/5mg

OLOMAX 20/5/10mg

Olmesartan 20 mg/Amlodipine 5 mg

Outcomes

Primary Outcome Measures

Rate of change in measured LDL-C (mLDL-C)
mLDL-C

Secondary Outcome Measures

Rate of change in measured LDL-C (mLDL-C)
mLDL-C
Rate of change in cLDL-C
cLDL-C
Rate of change in lipid profile(without LDL-C)
Total cholesterol, HDL-C, Triglyceride, mLDL-C/HDL-C ratio, hs-CRP, Apo A-1, Apo B, Apo B/Apo A-1 ratio
Proportion of subjects who reached in mLDL-C < 70mg/dL
mLDL-C < 70mg/dL
Proportion of subjects who reached in mLDL-C < 100mg/dL
mLDL-C < 100mg/dL
Changes and rate of change in sitSBP
sitSBP
Changes and rate of change in sitDBP
sitDBP
Proportion of subjects who reached the therapeutic goal
sitSBP<140mmHg and sitDBP<90mmHg
Changes and rate of change in glucose metabolic profile
Fasting plasma glucose (FPG), Fructosamine, HbA1c

Full Information

First Posted
October 8, 2019
Last Updated
November 7, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT04120753
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
OLOMAX 20/5/5mg
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
OLOMAX 20/5/10mg
Arm Title
Treatment 3
Arm Type
Active Comparator
Arm Description
Olmesartan 20 mg/Amlodipine 5 mg
Intervention Type
Drug
Intervention Name(s)
OLOMAX 20/5/5mg
Other Intervention Name(s)
Olomax Tablet
Intervention Description
Tablets, Oral, QD
Intervention Type
Drug
Intervention Name(s)
OLOMAX 20/5/10mg
Other Intervention Name(s)
Olomax Tablet
Intervention Description
Tablets, Oral, QD
Intervention Type
Drug
Intervention Name(s)
Olmesartan 20 mg/Amlodipine 5 mg
Other Intervention Name(s)
Sevikar HCT
Intervention Description
Tablets, Oral, QD
Primary Outcome Measure Information:
Title
Rate of change in measured LDL-C (mLDL-C)
Description
mLDL-C
Time Frame
After 8 weeks
Secondary Outcome Measure Information:
Title
Rate of change in measured LDL-C (mLDL-C)
Description
mLDL-C
Time Frame
After 4 weeks
Title
Rate of change in cLDL-C
Description
cLDL-C
Time Frame
After 4 weeks and 8 weeks
Title
Rate of change in lipid profile(without LDL-C)
Description
Total cholesterol, HDL-C, Triglyceride, mLDL-C/HDL-C ratio, hs-CRP, Apo A-1, Apo B, Apo B/Apo A-1 ratio
Time Frame
After 4 weeks and 8 weeks
Title
Proportion of subjects who reached in mLDL-C < 70mg/dL
Description
mLDL-C < 70mg/dL
Time Frame
After 4 weeks and 8 weeks
Title
Proportion of subjects who reached in mLDL-C < 100mg/dL
Description
mLDL-C < 100mg/dL
Time Frame
After 4 weeks and 8 weeks
Title
Changes and rate of change in sitSBP
Description
sitSBP
Time Frame
After 4 weeks and 8 weeks
Title
Changes and rate of change in sitDBP
Description
sitDBP
Time Frame
After 4 weeks and 8 weeks
Title
Proportion of subjects who reached the therapeutic goal
Description
sitSBP<140mmHg and sitDBP<90mmHg
Time Frame
After 8 weeks
Title
Changes and rate of change in glucose metabolic profile
Description
Fasting plasma glucose (FPG), Fructosamine, HbA1c
Time Frame
After 4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both man and woman who is over 19 years old Patients with hypertension Persons with mLDL ≥ 130mg/dL (low risk for cardiovascular disease) or mLDL ≥ 100mg/dL (intermediate risk for cardiovascular disease) Written informed consent Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inho Chae
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daewoong pharmatceutical
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

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