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Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

D

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

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)

Trial contacts and locations

1

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Central trial contact

Hyunju Shin; Daewoong clinical

Data sourced from clinicaltrials.gov

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