HypertensionPhase 3NCT04388215
Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet
A Phase 3 study testing CKD-828, D326 and D337 in people with Hypertension and Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension, Dyslipidemias
- What is being tested?
- CKD-828, D326 and D337
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2019to Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 19 years and 75 years old(male or female)
- Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
- The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
- Agreement with written informed consent
Who cannot join
- Patients whose blood pressure measured at screening is one of the following:
- Mean Sitting Systolic Blood Pressure ≥ 200 mmHg or Mean Sitting Diastolic Blood Pressure ≥ 120 mmHg
- Difference in Mean Sitting Systolic Blood Pressure between patient's both arms ≥ 20 mmHg and Mean Sitting Diastolic Blood Pressure ≥ 10 mmHg
- Patients whose lipid level measured at screening is one of the following:
- Low Density Lipoprotein-C > 250 mg/dL or Triglyceride ≥ 500 mg/dL
- Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul
Chang Gyu Park, M.D, Ph.D.
About this study
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-828, D326, and D337 Combination Therapy in Hypertensive Patients With Dyslipidemia
to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
Read the detailed description
The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with Dyslipidemia.
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- CKD-828, CKD-828(placebo), D326, D326(placebo), D337
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-828Drug
orally, 1 tablet once a day for 8 weeks
CKD-828(placebo)Drug
orally, 1 tablet once a day for 8 weeks
D326Drug
orally, 1 tablet once a day for 8 weeks
D326(placebo)Drug
orally, 1 tablet once a day for 8 weeks
D337Drug
orally, 1 tablet once a day for 8 weeks
D337(placebo)Drug
orally, 1 tablet once a day for 8 weeks
D013Drug
orally, 1 tablet once a day for 8 weeks
D013(placebo)Drug
orally, 1 tablet once a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks Receives: Drug: CKD-828; Drug: D326; Drug: D337; Drug: D013(placebo) |
| Comparator group 1 | Active comparator | Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg
- CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks Receives: Drug: CKD-828; Drug: D326(placebo); Drug: D337(placebo); Drug: D013(placebo) |
| Comparator group 2 | Active comparator | Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg
- CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks Receives: Drug: CKD-828(placebo); Drug: D326; Drug: D337; Drug: D013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate from baseline in Low Density Lipoprotein-C
(compare treatment group with comparator group 1)
Measured: Baseline, 8 weeks
Change from baseline in Mean Sitting Systolic Blood Pressure
(compare treatment group with comparator group 2)
Measured: Baseline, 8 weeks
Secondary outcomes (7)
Change rate from baseline in Low Density Lipoprotein-C
Measured: Baseline, 4 weeks
Change from baseline in Low Density Lipoprotein-C
Measured: Baseline, 4 weeks, 8 weeks
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C
Measured: Baseline, 4 weeks, 8 weeks
Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks
Measured: Baseline, 4 weeks, 8 weeks
Change from baseline in Mean Sitting Systolic Blood Pressure
Measured: Baseline, 4 weeks
Change from baseline in Mean Sitting Diastolic Blood Pressure
Measured: Baseline, 4 weeks, 8 weeks
Normalization rate of blood pressure after 4 weeks and 8 weeks
Blood Pressure < 140/90 mmHg
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start23 Oct 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
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
- NCT04388215
- Sponsor's protocol ID
- A86_03HT/DL1905
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 14 May 2020
- 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 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-828, D326, and D337 Combination Therapy in Hypertensive Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT04388215
- Acronym / sponsor ID
- A86_03HT/DL1905
- Conditions
- Hypertension, Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 14 May 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.
to evaluate the efficacy and safety of CKD-828, D326, and D337 combination therapy in Hypertensive patients with Dyslipidemia
Detailed description
The purpose of this phase III study was to evaluate the efficacy and safety of CKD-348(CKD-828, D326, D337) tablet administration for treatment period(8 weeks) in essential hypertesive patients with Dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: CKD-828, Drug: D326, Drug: D337, Drug: D013(placebo)Drug: CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg - CKD-828 80/5mg, D326 20mg, D337 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks |
| Comparator group 1 | Active comparator | Drug: CKD-828, Drug: D326(placebo), Drug: D337(placebo), Drug: D013(placebo)Drug: CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D013(placebo) 80mg - CKD-828 80/5mg, D326(placebo) 20mg, D337(placebo) 10mg, D337(placebo) 10mg, D013(placebo) 80mg, orally, 1 tablet once a day for 8 weeks |
| Comparator group 2 | Active comparator | Drug: CKD-828(placebo), Drug: D326, Drug: D337, Drug: D013Drug: CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg - CKD-828(placebo) 80/5mg, D326 20mg, D337 10mg, D013 80mg, orally, 1 tablet once a day for 8 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 19 years and 75 years old(male or female)
- Diagnosed essential hypertensive patients with dyslipidemia or the patients who has been taking antihypertensive and antidyslipidemic drugs
- The patients who can stop taking antihypertensive and antidyslipidemic drugs accroding to Principle Investigator's opinion
- Agreement with written informed consent
Key exclusion criteria (6 listed)
- Patients whose blood pressure measured at screening is one of the following:
- Patients whose lipid level measured at screening is one of the following:
- Patients diagnosed with secondary hypertension or suspected of secondary hypertension(coarctation of aorta, primary aldosteronism, etc).
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-828orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 1, Treatment group |
| CKD-828(placebo)orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 2 |
| D326orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 2, Treatment group |
| D326(placebo)orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 1 |
| D337orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 2, Treatment group |
| D337(placebo)orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 1 |
| D013orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 2 |
| D013(placebo)orally, 1 tablet once a day for 8 weeks | Drug | Comparator group 1, Treatment group |
Primary outcome
Change rate from baseline in Low Density Lipoprotein-C
Time frame: Baseline, 8 weeks
(compare treatment group with comparator group 1)
Change from baseline in Mean Sitting Systolic Blood Pressure
Time frame: Baseline, 8 weeks
(compare treatment group with comparator group 2)
7 secondary outcomes
Change rate from baseline in Low Density Lipoprotein-C
Time frame: Baseline, 4 weeks
Change from baseline in Low Density Lipoprotein-C
Time frame: Baseline, 4 weeks, 8 weeks
Change and change rate from baseline in Total Cholesterol, Triglyceride, High Density Lipoprotein-C
Time frame: Baseline, 4 weeks, 8 weeks
Low Density Lipoprotein-C target achievement rate accroding to National Cholesterol Education Program(NCEP) Third Adult Treatment Panel(ATP III) guideline at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Change from baseline in Mean Sitting Systolic Blood Pressure
Time frame: Baseline, 4 weeks
Change from baseline in Mean Sitting Diastolic Blood Pressure
Time frame: Baseline, 4 weeks, 8 weeks
Normalization rate of blood pressure after 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- 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.
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 CKD-828, D326 and D337 in people with Hypertension and Dyslipidemias, 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 4 inclusion and 6 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 14 May 2020. 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. 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 ChangGyu Park, M.D, Ph.D (+82-2-2626-3019, parkch@kumc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change rate from baseline in Low Density Lipoprotein-C (time frame: Baseline, 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 14 May 2020.