Status:
UNKNOWN
A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Age of 18 or above
- Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
- Ability to provide written informed consent
Exclusion
- 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%
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT02206165
Start Date
March 1 2014
End Date
June 1 2015
Last Update
March 30 2015
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam, South Korea