Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120753
• Other study ID #: DWJ1351_P401
• Status: Completed
• Phase: Phase 4
• Start date: August 26, 2019
• Est. completion date: July 6, 2021

Study information

• Verified date: October 2019
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• OLOMAX 20/5/5mg
Tablets, Oral, QD
• OLOMAX 20/5/10mg
Tablets, Oral, QD
• Olmesartan 20 mg/Amlodipine 5 mg
Tablets, Oral, QD

Locations

Country	Name	City	State
Korea, Republic of	Daewoong pharmatceutical	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in measured LDL-C (mLDL-C)	mLDL-C	After 8 weeks
Secondary	Rate of change in measured LDL-C (mLDL-C)	mLDL-C	After 4 weeks
Secondary	Rate of change in cLDL-C	cLDL-C	After 4 weeks and 8 weeks
Secondary	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	After 4 weeks and 8 weeks
Secondary	Proportion of subjects who reached in mLDL-C < 70mg/dL	mLDL-C < 70mg/dL	After 4 weeks and 8 weeks
Secondary	Proportion of subjects who reached in mLDL-C < 100mg/dL	mLDL-C < 100mg/dL	After 4 weeks and 8 weeks
Secondary	Changes and rate of change in sitSBP	sitSBP	After 4 weeks and 8 weeks
Secondary	Changes and rate of change in sitDBP	sitDBP	After 4 weeks and 8 weeks
Secondary	Proportion of subjects who reached the therapeutic goal	sitSBP<140mmHg and sitDBP<90mmHg	After 8 weeks
Secondary	Changes and rate of change in glucose metabolic profile	Fasting plasma glucose (FPG), Fructosamine, HbA1c	After 4 weeks and 8 weeks