Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension
Essential Hypertension
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination
Eligibility Criteria
Inclusion Criteria: Signed informed consent Aged ≥ 65 with essential hypertension Patient with uncontrolled essential hypertension at screening If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP < 200 mmHg Medication compliance of investigational product (Run-in) > 70 % Patient who has measured nighttime blood pressure more than 7 times from the night before the randomized date to the morning of the day of the randomized date (22:00~5:59) Patient with uncontrolled essential hypertension at Visit 2 140 mmHg ≤ MSSBP < 200 mmHg Exclusion Criteria: Patient who has secondary hypertension or suspected of secondary hypertension Patient who has orthostatic hypotension with symptoms Patient who has severe hypotension and severe heart disease (NYHA class III~IV) Patient who has been diagnosed with or treated with the following diseases within the last 6 months judged by the investigator to be clinically significant Patient who has ischemic heart disease, peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass surgery Patient who has clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia judged clinically significant by the investigator Patient who has hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, aortic valve hemodynamically significant or mitral valve stenosis/reflux Patient who has severe cerebrovascular disease Known moderate or malignant retinopathy Patient who has sleep disorders or apnea during sleep Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products Patient who has untreated addison's disease, symptomatic hyperuricemia, hyperparathyroidism, sympathetic nerve resection, shock patients Patient with anuria History of malignant tumor Patient with any chronic inflammation disease needed to chronic inflammation therapy Patient with mental defects that may interfere with participation in clinical trials Patient who has history of drug allergic reactions Patient who has angioedema related to ACE inhibitors, ARBs or diuretics Patient who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorpiton. Known hypersensitivity to components of the investigational product Patient who is unable to stop taking prohibited drugs Test results showing the following values at screening The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and 2nd measurements Hepatic or renal dysfunction as defined by the following laboratory parameters (eGFR < 30 mL/min/1.73m2, Serum creatinine ≥ 3 mg/dL, AST/ALT > UNL X 3) Hypokalemia (Serum K < 3.0 mmol/L) or hyperkalemia (Serum K > 5.5 mmol/L), hyponatremia (Serum Na < 132.0 mmol/L) or uncontrolled diabetes (HbA1c > 9.0%) Pregnant or lactating women Patient who is unable to maintain proper night sleep History of drug or alcohol dependency within 1 year prior to screening Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical Administration of other investigational products within 3 months prior to screening. An impossible one who participates in clinical trial by investigator's decision
Sites / Locations
- The Catholic University of Korea Bucheon St.Mary's Hospital
- The Catholic University of Korea Daejeon ST. Mary's Hospital
- Chonnam National University Hospital
- The Catholic University of Korea, ST. Vincent's Hospital
- he Catholic University of Korea, Incheon ST. Mary's Hospital
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
- Hanyang university medical center
- The Catholic University of Korea
- The Catholic University of Korea, Yeouido ST. Mary's Hospital
- Korea University Guro Hospital
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
- Seoul national University Budang hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period
Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period