Dyslipidemia Patients With HypertensionPhase 3NCT04312698
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386
A Phase 3 study testing D013, D326, D337 in people with Dyslipidemia Patients With Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemia Patients With Hypertension
- What is being tested?
- D013, D326, D337
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Aug 2019to 18 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis.
- Subjects who agreed to participate in this clinical trial voluntarily.
Who cannot join
- Subjects who were satisfied specific blood pressure levels that measured at screening period.
- Subjects who were satisfied specific lipid levels that measured at screening period.
- Subjects who cannot participate in a clinical trial based on the PI's judgment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Medical Center Severance Hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386
- Conditions
- Dyslipidemia Patients With Hypertension
- Being tested
- D013, D326, D337, placebo of D013, D326, D337, D013, placebo of D326, placebo of D337
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D013, D326, D337Drug
Also called Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337
placebo of D013, D326, D337Drug
Also called Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013
D013, placebo of D326, placebo of D337Drug
Also called Drugs are consist of antihypertensive agent and antihyperlipidemic agent
Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Not described Receives: Drug: D013, D326, D337 |
| Comparator Group 1 | Placebo comparator | Not described Receives: Drug: placebo of D013, D326, D337 |
| Comparator Group 2 | Placebo comparator | Not described Receives: Drug: D013, placebo of D326, placebo of D337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate from baseline in LDL-C
Compare experimental group 1 with comparator group 1
Measured: 8 weeks after drug administrations
Change from baseline in MSSBP
Compare experimental group 1 with comparator group 2
Measured: 8 weeks after drug administrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start29 Aug 2019
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia Patients With HypertensionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312698
- Sponsor's protocol ID
- A83_03DL/HT1903
- Status last verified
- Jul 2021
- First submitted
- 12 Mar 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04312698
- Acronym / sponsor ID
- A83_03DL/HT1903
- Conditions
- Dyslipidemia Patients With Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 18 Mar 2020 (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.
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: D013, D326, D337 |
| Comparator Group 1 | Placebo comparator | Drug: placebo of D013, D326, D337 |
| Comparator Group 2 | Placebo comparator | Drug: D013, placebo of D326, placebo of D337 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis.
- Subjects who agreed to participate in this clinical trial voluntarily.
Key exclusion criteria (3 listed)
- Subjects who were satisfied specific blood pressure levels that measured at screening period.
- Subjects who were satisfied specific lipid levels that measured at screening period.
- Subjects who cannot participate in a clinical trial based on the PI's judgment.
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 |
|---|---|---|
| D013, D326, D337Also: Drugs are consist of antihypertensive agent and antihyperlipidemic agentExperimental: Group 1 Patients assigned to this group are treated with D013, D326, D337 | Drug | Experimental Group 1 |
| placebo of D013, D326, D337Also: Drugs are consist of antihypertensive agent and antihyperlipidemic agentPlacebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013 | Drug | Comparator Group 1 |
| D013, placebo of D326, placebo of D337Also: Drugs are consist of antihypertensive agent and antihyperlipidemic agentPlacebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337 | Drug | Comparator Group 2 |
Primary outcome
Change rate from baseline in LDL-C
Time frame: 8 weeks after drug administrations
Compare experimental group 1 with comparator group 1
Change from baseline in MSSBP
Time frame: 8 weeks after drug administrations
Compare experimental group 1 with comparator group 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 D013, D326, D337 in people with Dyslipidemia Patients With Hypertension, run by Chong Kun Dang Pharmaceutical 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: finished, as of the sponsor's last update on 28 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate from baseline in LDL-C (time frame: 8 weeks after drug administrations). 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 28 Jul 2021.