NCT04161001

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 237 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2019-11-20
• Primary completion: 2021-11-20
• Completion: 2022-02-02
• First posted: 2019-11-13
• Last updated: 2019-11-13

Locations

1 site across 1 country: South Korea