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
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
age 18 years or older
stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure \>=95 and \<=115 mmHg
ability to provide written informed consent
You may not be if
severe hypertension defined as: a mean seated cuff diastolic blood pressure \>=116mmHg or a mean seated cuff systolic blood pressure \>=200mmHg
known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%
known severe or malignant retinopathy
hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT \> UNL X 2, serum creatinine \> UNL X 1.5
acute or chronic inflammatory status need to treatment
need to additional antihypertensive drugs during the study
need to concomitant medications known to affect blood pressure during the study
history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
known hypersensitivity related to either study drug
history of drug or alcohol dependency
any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
cannot swallow investigational products
administration of other study drugs within 4 weeks prior to randomization
premenopausal women(last menstration \< 1year) not using adequte contraception, pregnant or breast-feeding
history of malignancy including leukemia and lymphoma within the past 5 years
in investigator's judgment
Clareo Health | CKD-828 Primary Hypertension Trial(Dose-selection)
