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Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

Primary Purpose

Hypertension, Dyslipidemia

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
Amlodipine/Olmesartan 10/40mg (Combination drug)
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Dyslipidemia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe

Olmesartan, Rosuvastatin, Ezetimibe

Amlodpine, Olmesartan

Arm Description

co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe

co-administration of Olmesartan and Rosuvastatin, Ezetimibe

co-administration of Olmesartan, Amlodipine

Outcomes

Primary Outcome Measures

the change of MSSBP based on baseline between Treatment arm and control 1 arm
the change of LDL-C based on baseline between Treatment arm and control2 arm

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
November 10, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT04161001
Brief Title
Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Anticipated)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
February 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 ]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
237 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe
Arm Type
Experimental
Arm Description
co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe
Arm Title
Olmesartan, Rosuvastatin, Ezetimibe
Arm Type
Placebo Comparator
Arm Description
co-administration of Olmesartan and Rosuvastatin, Ezetimibe
Arm Title
Amlodpine, Olmesartan
Arm Type
Placebo Comparator
Arm Description
co-administration of Olmesartan, Amlodipine
Intervention Type
Drug
Intervention Name(s)
Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Amlodipine/Olmesartan 10/40mg (Combination drug)
Intervention Description
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)
Primary Outcome Measure Information:
Title
the change of MSSBP based on baseline between Treatment arm and control 1 arm
Time Frame
8 weeks
Title
the change of LDL-C based on baseline between Treatment arm and control2 arm
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daewoong clinical
Phone
+82-2-550-8800
Ext
8800
Email
shj@daewoong.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunju Shin
Email
shj@daewoong.co.kr
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jongwon Ha
Phone
82-02-2228-8448

12. IPD Sharing Statement

Learn more about this trial

Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

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