Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

November 10, 2019 updated by: Daewoong Pharmaceutical Co. LTD.

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

  • 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 ]

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

237

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:
          • Jongwon Ha
          • Phone Number: 82-02-2228-8448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe
co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe
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)
Placebo Comparator: Olmesartan, Rosuvastatin, Ezetimibe
co-administration of Olmesartan and Rosuvastatin, Ezetimibe
Drug: 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)
Placebo Comparator: Amlodpine, Olmesartan
co-administration of Olmesartan, Amlodipine
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the change of MSSBP based on baseline between Treatment arm and control 1 arm
Time Frame: 8 weeks
8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 20, 2019

Primary Completion (Anticipated)

November 20, 2021

Study Completion (Anticipated)

February 2, 2022

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 10, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 10, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWJ1451301

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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