Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sang Hyun Ihm, MD PhD
With
Daiichi Sankyo Korea Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Age
55–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male and female subjects \> 55 years
2. Subject who has consent to participate by signing on the informed consent form
3. Uncontrolled hypertensive patients defined as:
* Uncontrolled hypertensive: subjects who are mean SBP ≥ 140 mmHg after being treated with ARB(Valsartan 80mg or Candesartan 8mg) monotherapy during at least 4 weeks.
You may not be if
1. Secondary hypertension
2. SeSBP ≥ 180mmHg
3. SeSBP difference ≥ 20mmHg or SeDBP difference ≥ 10mmHg
4. A history of hypertensive encephalopathy, unstable angina, transient ischemic attack, MI, or any type of revascularization procedure within the last 6 months
5. Heart failure, second- or third-degree heart block, significant arrhythmia or valvular heart disease
6. Significant cardiovascular, cerebrovascular, renal, gastrointestinal, or hematologic disease, at the discretion of investigator
7. Creatinine clearance\<20mL/min and Renal artery stenosis, Renal Transplantation, Patients with only one kidney
8. Evidence of liver disease as indicated by alanine transaminase (ALT) and aspartate transaminase (AST) and/or total bilirubin ≥ 3 × the upper limit of normal (ULN)
9. Hyperkalemia (\>5.5mmol/L)
10. Patients with sodium depletion is not correct or Patients with fluid depletion is not correct
11. Chronic inflammation
12. Patients with severe eye-related disorders (Retinal bleeding within 6 months, Blindness, Hypertension complications with Retinal micro-aneurysms)
13. Diabetes mellitus
14. Hematologic/oncologic, neurologic and psychiatric diseases
15. Females who were pregnant, breastfeeding, planning a pregnancy or who were of childbearing potential
16. Contraindications for amlodipine, losartan, olmesartan medoxomil, or other ARBs
17. With known allergic reaction, lack of response or contraindication to Angiotensin II receptor antagonists
18. Mean DBP \> 110 mmHg
19. Patients who took antihyperlipidemic agents within 30 days
20. Subject who have participated in other clinical trial within the last one month
Clareo Health | Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to ARB monoTHerapy Using 24h ABPM
