HypertensionPhase 3NCT02586311
CKD-330 Phase 3 Trial in Amlodipine Non-responder
A Phase 3 study testing CKD-330 16/5mg and Amlodipine 5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-330 16/5mg and Amlodipine 5mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Sep 2016
- 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
- Age of 19 or above
- Essential hypertension with 140mmHg ≤ mean sitSBP < 180mmHg on target arm at Visit 2
- Ability to provide written informed consent
Who cannot join
- The difference between arms of sitSBP ≥ 20mmHg and/or sitDBP ≥ 10mmHg at Visit 1
- mean sitSBP ≥ 200mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 1
- mean sitSBP ≥ 180mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 2
- Known or suspected Secondary Hypertension
- Type I Diabetes Mellitus and Type II Diabetes Mellitus with HbA1c > 9%
- Patients with severe congestive heart failure(NYHA class III, IV)
Show all 21Show fewer
- Patient with ischemic heart disease, Ischemic cardiovascular disease, Valvular heart disease, arrhythmia requiring treatment within 3 months
- History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- History of severe or malignant retinopathy
- AST/ALT ≥ UNL*3, Serum creatinine ≥ UNL*1.5, K > 5.5mEq/L
- Patients with acute or chronic inflammatory status requiring treatment
- Patient who need to take antihypertensive drug besides Investigational products
- Patient must be treated with medications prohibited for concomitant use during the study period
- History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- History of malignant tumor within 5 years
- Patient who are dependent on drugs or alcohol within 6 months
- Hypersensitive to Candesartan/Amlodipine
- Women with pregnant, breast-feeding
- Patients treated with other investigational product within 30 days at first time taking the investigational product
- Not eligible to participate for the study at the discretion of investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 Versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Read the detailed description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
- Conditions
- Hypertension
- Being tested
- CKD-330 16/5mg, Amlodipine 5mg Placebo, CKD-330 16/5mg Placebo, Amlodipine 5mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-330 16/5mgDrug
Once a day, 8 weeks
Amlodipine 5mg PlaceboDrug
Also called Norvasc 5mg Placebo
Once a day, 8 weeks
CKD-330 16/5mg PlaceboDrug
Once a day, 8 weeks
Amlodipine 5mgDrug
Also called Norvasc 5mg
Once a day, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| CKD-330 16/5mg + Amlodipine 5mg placebo | Experimental | CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d. Receives: Drug: CKD-330 16/5mg; Drug: Amlodipine 5mg Placebo |
| CKD-330 16/5mg placebo + Amlodipine 5mg | Active comparator | CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d. Receives: Drug: CKD-330 16/5mg Placebo; Drug: Amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of sitSBP(sitting Systolic blood pressure)
Measured: From baseline at week 8
Secondary outcomes (4)
The mean change of sitSBP(sitting Systolic blood pressure)
Measured: From baseline at week 4
The mean change of sitDBP(sitting diastolic blood pressure)
Measured: From baseline at week 4 and week 8
Blood Pressure Control rate
Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg
Measured: From baseline to week 8
Blood Pressure Response rate
sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg
Measured: From baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionSep 2016
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang Gyu Park, M.D, Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586311
- Sponsor's protocol ID
- 144HT15027
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2015
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. 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 a CKD-330 Versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
- ClinicalTrials.gov ID
- NCT02586311
- Acronym / sponsor ID
- 144HT15027
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Oct 2015 (estimated)
- 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.
Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Detailed description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-330 16/5mg + Amlodipine 5mg placebo | Experimental | Drug: CKD-330 16/5mg, Drug: Amlodipine 5mg PlaceboCKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d. |
| CKD-330 16/5mg placebo + Amlodipine 5mg | Active comparator | Drug: CKD-330 16/5mg Placebo, Drug: Amlodipine 5mgCKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 19 or above
- Essential hypertension with 140mmHg ≤ mean sitSBP < 180mmHg on target arm at Visit 2
- Ability to provide written informed consent
Key exclusion criteria (21 listed)
- The difference between arms of sitSBP ≥ 20mmHg and/or sitDBP ≥ 10mmHg at Visit 1
- mean sitSBP ≥ 200mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 1
- mean sitSBP ≥ 180mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 2
- Known or suspected Secondary Hypertension
- Type I Diabetes Mellitus and Type II Diabetes Mellitus with HbA1c > 9%
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-330 16/5mgOnce a day, 8 weeks | Drug | CKD-330 16/5mg + Amlodipine 5mg placebo |
| Amlodipine 5mg PlaceboAlso: Norvasc 5mg PlaceboOnce a day, 8 weeks | Drug | CKD-330 16/5mg + Amlodipine 5mg placebo |
| CKD-330 16/5mg PlaceboOnce a day, 8 weeks | Drug | CKD-330 16/5mg placebo + Amlodipine 5mg |
| Amlodipine 5mgAlso: Norvasc 5mgOnce a day, 8 weeks | Drug | CKD-330 16/5mg placebo + Amlodipine 5mg |
Primary outcome
The mean change of sitSBP(sitting Systolic blood pressure)
Time frame: From baseline at week 8
4 secondary outcomes
The mean change of sitSBP(sitting Systolic blood pressure)
Time frame: From baseline at week 4
The mean change of sitDBP(sitting diastolic blood pressure)
Time frame: From baseline at week 4 and week 8
Blood Pressure Control rate
Time frame: From baseline to week 8
Blood Pressure Response rate
Time frame: From baseline to week 8
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 6 Oct 2016.
- 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.
Chang Gyu Park, M.D, Ph.D principal investigator
Korea University Guro 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-330 16/5mg and Amlodipine 5mg in people 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 3 inclusion and 21 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 6 Oct 2016. 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?
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?
The mean change of sitSBP(sitting Systolic blood pressure) (time frame: From baseline at week 8). 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 6 Oct 2016.