A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
NCT ID: NCT02206165
Last Updated: 2015-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
456 participants
INTERVENTIONAL
2014-03-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Candesartan 8mg + Amlodipine 5mg
Candesartan 8mg + Amlodipine 5mg, po, q.d.
Candesartan 8mg
Once a day, 8 weeks
Amlodipine 5mg
Once a day, 8 weeks
Candesartan 8mg + Amlodipine 10mg
Candesartan 8mg + Amlodipine 10mg, po, q.d.
Candesartan 8mg
Once a day, 8 weeks
Amlodipine 10mg
Once a day, 8 weeks
Candesartan 16mg + Amlodipine 5mg
Candesartan 16mg + Amlodipine 5mg, po, q.d.
Candesartan 16mg
Once a day, 8 weeks
Amlodipine 5mg
Once a day, 8 weeks
Candesartan 16mg + Amlodipine 10mg
Candesartan 16mg + Amlodipine 10mg, po, q.d.
Candesartan 16mg
Once a day, 8 weeks
Amlodipine 10mg
Once a day, 8 weeks
Candesartan 8mg
Candesartan 8mg, po, q.d.
Candesartan 8mg
Once a day, 8 weeks
Candesartan 16mg
Candesartan 16mg, po, q.d.
Candesartan 16mg
Once a day, 8 weeks
Amlodipine 5mg
Amlodipine 5mg, po, q.d.
Amlodipine 5mg
Once a day, 8 weeks
Amlodipine 10mg
Amlodipine 10mg, po, q.d.
Amlodipine 10mg
Once a day, 8 weeks
Interventions
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Candesartan 8mg
Once a day, 8 weeks
Candesartan 16mg
Once a day, 8 weeks
Amlodipine 5mg
Once a day, 8 weeks
Amlodipine 10mg
Once a day, 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
* Ability to provide written informed consent
Exclusion Criteria
* 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%
* 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
18 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Cheol-Ho Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Cheol-Ho Kim, M.D., Ph.D.
Role: primary
Other Identifiers
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144HT13021
Identifier Type: -
Identifier Source: org_study_id
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