Atrial FibrillationPhase 3NCT03950843
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
A Phase 3 study testing CKD-825 in people with Atrial Fibrillation, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CKD-825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2019to Dec 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
- Outpatients aged ≥ 19 years with persistent or permanent Atrial Fibrillation
- Patients with modified EHRA(The European Heart Rhythm Association score of atrial fibrillation) score ≥ 2a
- Patients with resting HR ≥ 80 beats per minute(bpm)
- Patients with 24-h mHR ≥ 80 bpm on Holter ECG
Who cannot join
- Treatment with antiarrhythmics within 2 weeks(Those who had washout period can be included)
- Pacemaker or implantable cardioverter defibrillator
- Catheter ablation for atrial fibrillation within 12 weeks before first investigational product(IP) administration
- Treatment for heart failure (New York Heart Association functional class 4)
- Myocardial infarction or unstable angina pectoris within 12 weeks before first IP administration
- Wolff-Parkinson-White syndrome
Show all 9Show fewer
- Hepatic or renal disorder
- Systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg
- Uncontrolled Diabetes(HbA1c > 9%)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jong-ll
Seoul
Jong-ll Chio, M.D, Ph.D, stabler92@gmail.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo Control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
Read the detailed description
A Multi-center, Randomized, Double-blind, Placebo control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Being tested
- CKD-825, Placebo oral capsule
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-825Drug
Also called Test
- Dosage Form: capsule
- Dosage: 3 types(low/medium/high dose)
- Frequency: QD(once daily) administration
Placebo oral capsuleDrug
Also called Reference
Placebo of CKD-825
- Dosage Form: capsule
- Dosage: NA
- Frequency: QD administration
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | * Patients assigned to this group are treated with 1 capsule of CKD-825 and 2 placebo capsules(the placebo of CKD-825)
* The necessity of a dose titration is adjudicated every 2 weeks.
* After unblinding at the end of Administration Period, only patients in experimental group are treated with 1 capsule of CKD-825 for additional 4 weeks of Extension Period. Receives: Drug: CKD-825; Drug: Placebo oral capsule |
| Placebo Group | Placebo comparator | * Patients assigned to this group are treated with 3 placebo capsules (the placebo of CKD-825)
* The necessity of a dose titration is adjudicated every 2 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
To compare experimental group with placebo group
Measured: at week 6 after first drug administration
Secondary outcomes (4)
Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value
To compare experimental group with placebo group
Measured: at week 2, week 4, week 6 and week 10 after first drug administration
Percentages of patients whose resting HR on 12-lead ECG achieved below 110 bpm at week 6 and week 10 among those with resting HR ≥ 110 bpm from baseline
To compare experimental group with placebo group
Measured: 2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration
Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm
To compare experimental group with placebo group
Measured: at week 6 and week 10 after first drug administration
Change in modified EHRA score(European Heart Rhythm Association score of atrial fibrillation) compared with the baseline value
To compare experimental group with placebo group
Measured: at week 2, week 4, week 6 and week 10 after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start23 Apr 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaemin Park, M.D, Ph.D, Principal investigator, Gachon University Gil Medical CenterYongseog Oh, M.D, Ph.D, Principal investigator, The Catholic University of KoreaJinBae Kim, M.D, Ph.D, Principal investigator, Kyunghee University HospitalSeongwook Han, M.D, Ph.D, Principal investigator, Keimyung Universtiy Dongsan Medical CenterJongsung Park, M.D, Ph.D, Principal investigator, Dong-A UniversityYeonggeun On, M.D, Ph.D, Principal investigator, Samsung Medical CenterKee-Jun Choi, M.D, Ph.D, Principal investigator, Asan Medical CenterSang-Weon Park, M.D, Ph.D, Principal investigator, Sejong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950843
- Sponsor's protocol ID
- 125AF18022
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 15 May 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 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo Control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03950843
- Acronym / sponsor ID
- 125AF18022
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 May 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.
to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
Detailed description
A Multi-center, Randomized, Double-blind, Placebo control, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of CKD-825 in Patients With Atrial Fibrillation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: CKD-825, Drug: Placebo oral capsule* Patients assigned to this group are treated with 1 capsule of CKD-825 and 2 placebo capsules(the placebo of CKD-825) * The necessity of a dose titration is adjudicated every 2 weeks. * After unblinding at the end of Administration Period, only patients in experimental group are treated with 1 capsule of CKD-825 for additional 4 weeks of Extension Period. |
| Placebo Group | Placebo comparator | Drug: Placebo oral capsule* Patients assigned to this group are treated with 3 placebo capsules (the placebo of CKD-825) * The necessity of a dose titration is adjudicated every 2 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients aged ≥ 19 years with persistent or permanent Atrial Fibrillation
- Patients with modified EHRA(The European Heart Rhythm Association score of atrial fibrillation) score ≥ 2a
- Patients with resting HR ≥ 80 beats per minute(bpm)
- Patients with 24-h mHR ≥ 80 bpm on Holter ECG
Key exclusion criteria (9 listed)
- Treatment with antiarrhythmics within 2 weeks(Those who had washout period can be included)
- Pacemaker or implantable cardioverter defibrillator
- Catheter ablation for atrial fibrillation within 12 weeks before first investigational product(IP) administration
- Treatment for heart failure (New York Heart Association functional class 4)
- Myocardial infarction or unstable angina pectoris within 12 weeks before first IP administration
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-825Also: Test* Dosage Form: capsule * Dosage: 3 types(low/medium/high dose) * Frequency: QD(once daily) administration | Drug | Experimental Group |
| Placebo oral capsuleAlso: ReferencePlacebo of CKD-825 * Dosage Form: capsule * Dosage: NA * Frequency: QD administration | Drug | Experimental Group, Placebo Group |
Primary outcome
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value
Time frame: at week 6 after first drug administration
To compare experimental group with placebo group
4 secondary outcomes
Change in resting heart rate(HR) on 12-lead electrocardiogram(ECG) compared with the baseline value
Time frame: at week 2, week 4, week 6 and week 10 after first drug administration
Percentages of patients whose resting HR on 12-lead ECG achieved below 110 bpm at week 6 and week 10 among those with resting HR ≥ 110 bpm from baseline
Time frame: 2 weeks, 4 weeks and 6 weeks and 10 weeks after first drug administration
Percentages of patients whose resting HR on 12-lead ECG achieved < 80 bpm
Time frame: at week 6 and week 10 after first drug administration
Change in modified EHRA score(European Heart Rhythm Association score of atrial fibrillation) compared with the baseline value
Time frame: at week 2, week 4, week 6 and week 10 after first drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Yaemin Park, M.D, Ph.D principal investigator
Gachon University Gil Medical Center
Yongseog Oh, M.D, Ph.D principal investigator
The Catholic University of Korea
JinBae Kim, M.D, Ph.D principal investigator
Kyunghee University Hospital
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-825 in people with Atrial Fibrillation, 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 9 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 15 May 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 Jong-ll Choi, M.D, Ph.D (+82-2-2072-4164, stabler92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean 24-hour heart rate(24-h mHR) compared with the baseline value (time frame: at week 6 after first drug administration). 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 15 May 2019.