The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy

A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy

Inclusion criteria

• More than 19 years in hypertension patient
• Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization

• Clinic MSSBP ≥ 140mmHg
• Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease

• Diabetes mellitus

• Before screening, diagnosed with diabetes mellitus being treated with oral hypoglycemic agents at least 30 days OR
• Patients who meet the following results of laboratory tests at the time of randomization. : Fasting plasma glucose ≥ 126mg/dL
• Chronic kidney disease

• Patients who meet the following results of laboratory tests at the time of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration rate ≤ 60mL/min/1.73m2
• Patient who decided to participate and signed on an informed consent form willingly

Exclusion criteria

• Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg at the time of Screening and Randomization
• As night workers who sleep during the day and whose working hours including 00:00 to 04:00
• Abnormal laboratory test results

• Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3
• Serum creatinine > Upper normal limit X 4
• Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.
• Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months
• Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
• Patient who is planning for a renal transplantation during the trial
• Severe or malignant retinopathy
• Acute of chronic inflammatory status requiring treatment
• A history of cancer within five years
• A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
• Severe hypersensitivity to amlodipine or telmisartan
• Surgical or medical conditions

• History of major gastrointestinal surgery
• History of active inflammatory bowel syndrome within 12 months
• Abnormal pancreatic functions
• Gastrointestinal/rectal bleeding
• Urinary tract obstruction
• Need for other antihypertensive drugs during the trial
• Need for prohibited medication specified in the protocol
• Administration of other Investigational Product within 30 days
• History of drug or alcohol abuse within 6 months
• Pregnant, breast-feeding and childbearing age who don't use adequate contraception
• Another clinical condition in investigator's judgement