- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161001
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
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 Contact
- Name: Daewoong clinical
- Phone Number: 8800 +82-2-550-8800
- Email: shj@daewoong.co.kr
Study Contact Backup
- Name: Hyunju Shin
- Email: shj@daewoong.co.kr
Study Locations
-
-
-
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
17 years to 78 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
|
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
|
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
|
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
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
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Lipid Metabolism Disorders
- Hypertension
- Dyslipidemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Rosuvastatin Calcium
- Olmesartan
- Olmesartan Medoxomil
- Ezetimibe
- Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
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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