Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

Hypertension, Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161001
• Other study ID #: DW_DWJ1451301
• Status: Recruiting
• Phase: Phase 3
• Start date: November 20, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: November 2019
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Daewoong clinical
• Phone: +82-2-550-8800
• Email: shj[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 237
• Est. completion date: February 2, 2022
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension
• Hypertension, Dyslipidemia

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	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	the change of MSSBP based on baseline between Treatment arm and control 1 arm		8 weeks
Primary	the change of LDL-C based on baseline between Treatment arm and control2 arm		8 weeks