Hypertensive Patients With DyslipidemiaPhase 3NCT03583905
Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet
A Phase 3 study testing CKD-330, D086 and D723 in people with Hypertensive Patients With Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 16 sites in South Korea.
Trial summary
To Evaluate the Efficacy and Safety of CKD-333 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertensive Patients With Dyslipidemia
- What is being tested?
- CKD-330, D086 and D723
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 4 Apr 2018to 17 Jul 2019
- 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
- Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period
- Lipid levels measured after run-in period were:
- Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
- Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
- Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL
Who cannot join
- Patients whose blood pressures measured at Visit 2 were:
- Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg
- Patients who had lipid levels measured at Visit 2
- Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or TG ≥ 500 mg / dL
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Dong-A University Hospital
Busan
Pusan National University Hospital
Busan
Chonnam National University Hospital
Gwangju
Gachon University Gil Hospital
Incheon
Catholic University Seoul St. Mary's Hospital
Seoul
Hanyang University Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyunghee University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul Asan Medical Center
Seoul
Seoul Medical Center
Seoul
Yonsei University Medical Center Gangnam Severance Hospital
Seoul
Yonsei University Medical Center Severance Hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia
To Evaluate the Efficacy and Safety of CKD-333
Read the detailed description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia
- Conditions
- Hypertensive Patients With Dyslipidemia
- Being tested
- CKD-330, Placebo of CKD-330, D086, Placebo of D086, D723
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-330Drug
CKD-330 Tab.
Placebo of CKD-330Drug
Placebo of CKD-330 Tab.
D086Drug
D086 Tab.
Placebo of D086Drug
Placebo of D086 Tab.
D723Drug
D723 Tab.
Placebo of D723Drug
Placebo of D723 Tab.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Patients assigned to this group are treated with CKD-330, D086 Receives: Drug: CKD-330; Drug: D086; Drug: Placebo of D723 |
| Placebo Group 1 | Placebo comparator | Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086) Receives: Drug: CKD-330; Drug: Placebo of D086; Drug: Placebo of D723 |
| Placebo Group 2 | Placebo comparator | Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330) Receives: Drug: Placebo of CKD-330; Drug: D086; Drug: D723 |
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 placebo group 1
Measured: 8 weeks after drug administrations
Change from baseline in MSSBP
Compare experimental group 1 with placebo group 2
Measured: 8 weeks after drug administrations
Secondary outcomes (12)
Change rate from baseline in LDL-C
Compare experimental group 1 with placebo group 1
Measured: 4 weeks after drug administrations
Change from baseline in LDL-C
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
Change from baseline in MSSBP(mmHg)
Compare experimental group 1 with placebo group 2
Measured: 4 weeks after drug administrations
Change from baseline in MSDBP
Compare experimental group 1 with placebo group 2
Measured: 4, 8 weeks after drug administrations
Attainment of normal blood pressure as defined by JNC Ⅶ
Compare experimental group 1 with placebo group 2
Measured: 4, 8 weeks after drug administrations
Change from baseline in TC
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
Change from baseline in TG
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
Change from baseline in HDL-C
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
change rate from baseline in TC
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
change rate from baseline in TG
Compare experimental group 1 with placebo group 1
Measured: 4, 8 weeks after drug administrations
change rate from baseline in HDL-C
Compare experimental group 1 with placebo group 1
Measured: 4, 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 posted12 Jul 2018
- Study start4 Apr 2018
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Patients With DyslipidemiaStudies 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
- 154 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
- NCT03583905
- Sponsor's protocol ID
- 170HT/DL17007
- Status last verified
- Apr 2018
- First submitted
- 24 May 2018
- Last updated
- 24 Jul 2019
- Results posted
- 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 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT03583905
- Acronym / sponsor ID
- 170HT/DL17007
- Conditions
- Hypertensive Patients With Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 12 Jul 2018 (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.
To Evaluate the Efficacy and Safety of CKD-333
Detailed description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia
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: CKD-330, Drug: D086, Drug: Placebo of D723Patients assigned to this group are treated with CKD-330, D086 |
| Placebo Group 1 | Placebo comparator | Drug: CKD-330, Drug: Placebo of D086, Drug: Placebo of D723Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086) |
| Placebo Group 2 | Placebo comparator | Drug: Placebo of CKD-330, Drug: D086, Drug: D723Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period
- Lipid levels measured after run-in period were:
Key exclusion criteria (4 listed)
- Patients whose blood pressures measured at Visit 2 were:
- Patients who had lipid levels measured at Visit 2
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 |
|---|---|---|
| CKD-330CKD-330 Tab. | Drug | Experimental Group 1, Placebo Group 1 |
| Placebo of CKD-330Placebo of CKD-330 Tab. | Drug | Placebo Group 2 |
| D086D086 Tab. | Drug | Experimental Group 1, Placebo Group 2 |
| Placebo of D086Placebo of D086 Tab. | Drug | Placebo Group 1 |
| D723D723 Tab. | Drug | Placebo Group 2 |
| Placebo of D723Placebo of D723 Tab. | Drug | Experimental Group 1, Placebo Group 1 |
Primary outcome
Change rate from baseline in LDL-C
Time frame: 8 weeks after drug administrations
Compare experimental group 1 with placebo group 1
Change from baseline in MSSBP
Time frame: 8 weeks after drug administrations
Compare experimental group 1 with placebo group 2
12 secondary outcomes
Change rate from baseline in LDL-C
Time frame: 4 weeks after drug administrations
Change from baseline in LDL-C
Time frame: 4, 8 weeks after drug administrations
Attainment of LDL-C treatment goal as defined by NCEP ATP Ⅲ Guideline
Time frame: 4, 8 weeks after drug administrations
Change from baseline in MSSBP(mmHg)
Time frame: 4 weeks after drug administrations
Change from baseline in MSDBP
Time frame: 4, 8 weeks after drug administrations
Attainment of normal blood pressure as defined by JNC Ⅶ
Time frame: 4, 8 weeks after drug administrations
Change from baseline in TC
Time frame: 4, 8 weeks after drug administrations
Change from baseline in TG
Time frame: 4, 8 weeks after drug administrations
Change from baseline in HDL-C
Time frame: 4, 8 weeks after drug administrations
change rate from baseline in TC
Time frame: 4, 8 weeks after drug administrations
change rate from baseline in TG
Time frame: 4, 8 weeks after drug administrations
change rate from baseline in HDL-C
Time frame: 4, 8 weeks after drug administrations
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 24 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Hypertensive Patients With Dyslipidemia
Active, not recruitingObservational study
Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
Hypertension, Dyslipidemias
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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CKD-330, D086 and D723 in people with Hypertensive Patients With Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 16 sites 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 5 inclusion and 4 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 24 Jul 2019.