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Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

NCT04161001 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2019-11-13

No results posted yet for this study

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 \[ Time Frame: 8 weeks \]

Conditions

  • Hypertension, Dyslipidemia

Interventions

DRUG

Amlodipine/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)

DRUG

Olmesartan 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)

DRUG

Amlodipine/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)

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2021-11-20
Completion
2022-02-02

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04161001 on ClinicalTrials.gov