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Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

Phase 3
Conditions
Hypertension, Dyslipidemia
Interventions
Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)
Registration Number
NCT04161001
Lead Sponsor
Daewoong Pharmaceutical Co. LTD.
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 \[ Time Frame: 8 weeks \]

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
237
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Amlodpine, Olmesartan, Rosuvastatin, EzetimibeAmlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe
Amlodpine, OlmesartanAmlodipine/Olmesartan 10/40mg (Combination drug)co-administration of Olmesartan, Amlodipine
Olmesartan, Rosuvastatin, EzetimibeOlmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)co-administration of Olmesartan and Rosuvastatin, Ezetimibe
Primary Outcome Measures
NameTimeMethod
the change of MSSBP based on baseline between Treatment arm and control 1 arm8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm8 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital

🇰🇷

Seoul, Korea, Republic of

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