NCT04120753

Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	OLOMAX 20/5/5mg	Tablets, Oral, QD
DRUG	OLOMAX 20/5/10mg	Tablets, Oral, QD
DRUG	Olmesartan 20 mg/Amlodipine 5 mg	Tablets, Oral, QD

Timeline

• Start date: 2019-08-26
• Primary completion: 2021-07-06
• Completion: 2021-07-06
• First posted: 2019-10-09
• Last updated: 2024-07-01

Locations

1 site across 1 country: South Korea