Hypertension, DyslipidemiaPhase 3NCT04161001
Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451
A Phase 3 study testing Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug), Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug) and Amlodipine/Olmesartan 10/40mg (Combination drug) in people with Hypertension, Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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 ] Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug), Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug) and Amlodipine/Olmesartan 10/40mg (Combination drug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2019to 2 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 to 80 years
- patients with hypertension and hyperlipidemias
Who cannot join
- orthostatic hypotension
- History of ventricular tachycardia, atrial fibrillation
- uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Hyunju Shin contact
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jongwon Ha, 82-02-2228-8448
About this study
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
- 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 ]
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- 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)
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)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)
Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)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)
Amlodipine/Olmesartan 10/40mg (Combination drug)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)
| Study group | Role | What they receive |
|---|---|---|
| Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe | Experimental | co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe Receives: Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug) |
| Olmesartan, Rosuvastatin, Ezetimibe | Placebo comparator | co-administration of Olmesartan and Rosuvastatin, Ezetimibe Receives: Drug: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug) |
| Amlodpine, Olmesartan | Placebo comparator | co-administration of Olmesartan, Amlodipine Receives: Drug: Amlodipine/Olmesartan 10/40mg (Combination drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of MSSBP based on baseline between Treatment arm and control 1 arm
Measured: 8 weeks
the change of LDL-C based on baseline between Treatment arm and control2 arm
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start20 Nov 2019 (estimated)
- Primary completion20 Nov 2021 (estimated)
- Study completion2 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161001
- Sponsor's protocol ID
- DW_DWJ1451301
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04161001
- Acronym / sponsor ID
- DW_DWJ1451301
- Conditions
- Hypertension, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (estimated)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 2 Feb 2022 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe | Experimental | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)co-administration of Olmesartan, Amlodipine and Rosuvastatin, Ezetimibe |
| Olmesartan, Rosuvastatin, Ezetimibe | Placebo comparator | Drug: Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)co-administration of Olmesartan and Rosuvastatin, Ezetimibe |
| Amlodpine, Olmesartan | Placebo comparator | Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)co-administration of Olmesartan, Amlodipine |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19 to 80 years
- patients with hypertension and hyperlipidemias
Key exclusion criteria (3 listed)
- orthostatic hypotension
- History of ventricular tachycardia, atrial fibrillation
- uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Amlodpine, Olmesartan, Rosuvastatin, Ezetimibe |
| 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) | Drug | Olmesartan, Rosuvastatin, Ezetimibe |
| 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) | Drug | Amlodpine, Olmesartan |
Primary outcome
the change of MSSBP 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyunju Shin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug), Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug) and Amlodipine/Olmesartan 10/40mg (Combination drug) in people with Hypertension, Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daewoong clinical (+82-2-550-8800 ext. 8800, shj@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of MSSBP based on baseline between Treatment arm and control 1 arm (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.