Essential Hypertension
Conditions
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.
Interventions
DRUGCandesartan 8mg
Once a day, 8 weeks
DRUGCandesartan 16mg
Once a day, 8 weeks
DRUGAmlodipine 5mg
Once a day, 8 weeks
DRUGAmlodipine 10mg
Once a day, 8 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change of sitDBP (sitting diastolic blood pressure) | From baseline at week 8 |
Secondary
| Measure | Time frame |
|---|---|
| The mean change of sitDBP | From baseline at week 4 and week 8 |
| The mean change of sitSBP | From baseline at week 4 and 8 |
| Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg | From baseline at week 4 and 8 |
| Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg | At week 4 and 8 |
Countries
South Korea
Contacts
Primary ContactHyunKyung Oh
Outcome results
None listed