Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

A Multi-center, Randomized, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ1451 in Patients With Hypertension and Dyslipidemia

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04161001

Enrollment

237

Registered

2019-11-13

Start date

2019-11-20

Completion date

2022-02-02

Last updated

2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Dyslipidemia

Brief summary

* the change of sitSBP based on baseline between Treatment arm and control 1 arm \[ Time Frame: 8 weeks \] * the change of LDL-C based on baseline between Treatment arm and control2 arm \[ Time Frame: 8 weeks \]

Interventions

DRUGAmlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Olmetec Tab. 40mg(Olmesartan 40mg)

DRUGOlmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)

co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Sevikar tab. 10/40mg (Amlodipine/Olmesartan 10/40mg)

DRUGAmlodipine/Olmesartan 10/40mg (Combination drug)

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg, and placebo of Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg), Olmetec Tab. 40mg(Olmesartan 40mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age 19 to 80 years * patients with hypertension and hyperlipidemias

Exclusion criteria

* orthostatic hypotension * History of ventricular tachycardia, atrial fibrillation * uncontrolled diabetes mellitus

Design outcomes

Primary

Measure	Time frame
the change of MSSBP based on baseline between Treatment arm and control 1 arm	8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm	8 weeks

Countries

South Korea

Contacts

Primary ContactDaewoong clinical

shj@daewoong.co.kr+82-2-550-8800

Backup ContactHyunju Shin

shj@daewoong.co.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026