Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Hypertension, Dyslipidemia

Treatments: Drug: Amlodipine/Olmesartan 10/40mg (Combination drug); Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug); Drug: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04161001

DW_DWJ1451301

Details and patient eligibility

About

• 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 ]

Enrollment: 237 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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237 participants in 3 patient groups, including a placebo group

Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe

Experimental group

Description:

co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe

Treatment:

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)

Olmesartan, Rosuvastatin, Ezetimibe

Placebo Comparator group

Description:

co-administration of Olmesartan and Rosuvastatin, Ezetimibe

Treatment:

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

Amlodpine, Olmesartan

Placebo Comparator group

Description:

co-administration of Olmesartan, Amlodipine

Treatment:

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)