Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chong Kun Dang Pharmaceutical
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age of 19 or above
Inadequately controlled Essential hypertension at Screening
1. Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1
* Mean sitDBP ≥ 95mmHg on target arm
2. Taking antihypertensive drug but not controlled
* Mean sitDBP ≥ 90mmHg on target arm
Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy
* Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
Ability to provide written informed consent
You may not be if
The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
Patient with congestive heart failure(NYHA class III, IV)
Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
History of stroke, cerebral hemorrhage within 6 months
Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c \> 8.5%
History of severe or malignant retinopathy
AST/ALT \> UNL\*3, Serum creatinine \> UNL\*1.5, K \> 5.5mEq/L
Patient with acute or chronic inflammatory(treatment required) status
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
Hypersensitive to Candesartan/Amlodipine
Patient who are dependent on drugs or alcohol within 6 months
History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
Patients treated with other investigational product within 30 days at first time taking the investigational product
Women with pregnant, breast-feeding
History of malignant tumor within 5 years
Clareo Health | Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
