A 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 Hypertensio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001846
- Lead Sponsor
- Chong Kun Dang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 456
•Age of 18 or above
•Essential hypertension with 90mmHg = mean sitDBP = 115mmHg on target arm at Visit 3
•Ability to provide written informed consent
•Mean 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean change of sitDBP (sitting diastolic blood pressure), Strict superiority
- Secondary Outcome Measures
Name Time Method The mean change of sitDBP ;The mean change of sitSBP;Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg;Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg