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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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2016-01-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CKD-330 16/5mg + Amlodipine 5mg placebo
CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.
CKD-330 16/5mg
Once a day, 8 weeks
Amlodipine 5mg Placebo
Once a day, 8 weeks
CKD-330 16/5mg placebo + Amlodipine 5mg
CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.
CKD-330 16/5mg Placebo
Once a day, 8 weeks
Amlodipine 5mg
Once a day, 8 weeks
Interventions
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CKD-330 16/5mg
Once a day, 8 weeks
Amlodipine 5mg Placebo
Once a day, 8 weeks
CKD-330 16/5mg Placebo
Once a day, 8 weeks
Amlodipine 5mg
Once a day, 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Essential hypertension with 140mmHg ≤ mean sitSBP \< 180mmHg on target arm at Visit 2
* Ability to provide written informed consent
Exclusion Criteria
* 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)
* 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
19 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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Chang Gyu Park, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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144HT15027
Identifier Type: -
Identifier Source: org_study_id
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