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Lead
Chong Kun Dang Pharmaceutical
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
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age of 19 or above
Essential hypertension with 140mmHg ≤ mean sitSBP \< 180mmHg on target arm at Visit 2
Ability to provide written informed consent
You may not be if
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)
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
Clareo Health | CKD-330 Phase 3 Trial in Amlodipine Non-responder
