Essential HypertensionPhase 2NCT02206165
A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
A Phase 2 study testing Candesartan 8mg, Candesartan 16mg and Amlodipine 5mg in people with Essential Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Candesartan 8mg, Candesartan 16mg and Amlodipine 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Jun 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 or above
- Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
- Ability to provide written informed consent
Who cannot join
- nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
- History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8%
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- History of severe or malignant retinopathy
- AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L
- Patients with acute or chronic inflammatory status, autoimmune disease
- Patients who need to take antihypertensive drug besides Investigational products
- Patients must be treated with medications prohibited for concomitant use during study period
- Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
- Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- History of malignant tumor within 5 years
- Patients who are dependent on drugs or alcohol
- History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- Patients treated with other investigational product within 4 weeks at the time concents are obtained
- Women with pregnant, breast-feeding
- Not eligible to participate for study at the discretion of investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Cheol-Ho Kim, M.D., Ph.D.
Cheol-Ho Kim, M.D., Ph.D.
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.
- Conditions
- Essential Hypertension
- Being tested
- Candesartan 8mg, Candesartan 16mg, Amlodipine 5mg, Amlodipine 10mg
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan 8mgDrug
Once a day, 8 weeks
Candesartan 16mgDrug
Once a day, 8 weeks
Amlodipine 5mgDrug
Once a day, 8 weeks
Amlodipine 10mgDrug
Once a day, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Candesartan 8mg + Amlodipine 5mg | Experimental | Candesartan 8mg + Amlodipine 5mg, po, q.d. Receives: Drug: Candesartan 8mg; Drug: Amlodipine 5mg |
| Candesartan 8mg + Amlodipine 10mg | Experimental | Candesartan 8mg + Amlodipine 10mg, po, q.d. Receives: Drug: Candesartan 8mg; Drug: Amlodipine 10mg |
| Candesartan 16mg + Amlodipine 5mg | Experimental | Candesartan 16mg + Amlodipine 5mg, po, q.d. Receives: Drug: Candesartan 16mg; Drug: Amlodipine 5mg |
| Candesartan 16mg + Amlodipine 10mg | Experimental | Candesartan 16mg + Amlodipine 10mg, po, q.d. Receives: Drug: Candesartan 16mg; Drug: Amlodipine 10mg |
| Candesartan 8mg | Active comparator | Candesartan 8mg, po, q.d. Receives: Drug: Candesartan 8mg |
| Candesartan 16mg | Active comparator | Candesartan 16mg, po, q.d. Receives: Drug: Candesartan 16mg |
| Amlodipine 5mg | Active comparator | Amlodipine 5mg, po, q.d. Receives: Drug: Amlodipine 5mg |
| Amlodipine 10mg | Active comparator | Amlodipine 10mg, po, q.d. Receives: Drug: Amlodipine 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of sitDBP (sitting diastolic blood pressure)
Measured: From baseline at week 8
Secondary outcomes (4)
The mean change of sitDBP
Measured: From baseline at week 4 and week 8
The mean change of sitSBP
Measured: From baseline at week 4 and 8
Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
Measured: From baseline at week 4 and 8
Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
Measured: At week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheol-Ho Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206165
- Sponsor's protocol ID
- 144HT13021
- Status last verified
- Mar 2015
- First submitted
- 16 Jun 2014
- Last updated
- 30 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02206165
- Acronym / sponsor ID
- 144HT13021
- Conditions
- Essential Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 1 Aug 2014 (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.
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Candesartan 8mg + Amlodipine 5mg | Experimental | Drug: Candesartan 8mg, Drug: Amlodipine 5mgCandesartan 8mg + Amlodipine 5mg, po, q.d. |
| Candesartan 8mg + Amlodipine 10mg | Experimental | Drug: Candesartan 8mg, Drug: Amlodipine 10mgCandesartan 8mg + Amlodipine 10mg, po, q.d. |
| Candesartan 16mg + Amlodipine 5mg | Experimental | Drug: Candesartan 16mg, Drug: Amlodipine 5mgCandesartan 16mg + Amlodipine 5mg, po, q.d. |
| Candesartan 16mg + Amlodipine 10mg | Experimental | Drug: Candesartan 16mg, Drug: Amlodipine 10mgCandesartan 16mg + Amlodipine 10mg, po, q.d. |
| Candesartan 8mg | Active comparator | Drug: Candesartan 8mgCandesartan 8mg, po, q.d. |
| Candesartan 16mg | Active comparator | Drug: Candesartan 16mgCandesartan 16mg, po, q.d. |
| Amlodipine 5mg | Active comparator | Drug: Amlodipine 5mgAmlodipine 5mg, po, q.d. |
| Amlodipine 10mg | Active comparator | Drug: Amlodipine 10mgAmlodipine 10mg, po, q.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 or above
- Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
- Ability to provide written informed consent
Key exclusion criteria (19 listed)
- nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
- History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
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 |
|---|---|---|
| Candesartan 8mgOnce a day, 8 weeks | Drug | Candesartan 8mg, Candesartan 8mg + Amlodipine 10mg, Candesartan 8mg + Amlodipine 5mg |
| Candesartan 16mgOnce a day, 8 weeks | Drug | Candesartan 16mg, Candesartan 16mg + Amlodipine 10mg, Candesartan 16mg + Amlodipine 5mg |
| Amlodipine 5mgOnce a day, 8 weeks | Drug | Amlodipine 5mg, Candesartan 16mg + Amlodipine 5mg, Candesartan 8mg + Amlodipine 5mg |
| Amlodipine 10mgOnce a day, 8 weeks | Drug | Amlodipine 10mg, Candesartan 16mg + Amlodipine 10mg, Candesartan 8mg + Amlodipine 10mg |
Primary outcome
The mean change of sitDBP (sitting diastolic blood pressure)
Time frame: From baseline at week 8
4 secondary outcomes
The mean change of sitDBP
Time frame: From baseline at week 4 and week 8
The mean change of sitSBP
Time frame: From baseline at week 4 and 8
Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
Time frame: From baseline at week 4 and 8
Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
Time frame: At week 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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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.
Cheol-Ho Kim, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candesartan 8mg, Candesartan 16mg and Amlodipine 5mg in people with Essential 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 19 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 30 Mar 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 HyunKyung Oh (82-2-2194-0469, hkoh@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change of sitDBP (sitting diastolic 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 30 Mar 2015.