Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome
Randomized, Open Labeled Clinical Trial to Compare the Effectiveness of Amlodipine/Valsartan vs Hydrochlorothiazide/Telmisartan on Glucose Tolerance in Patients With Hypertension With Metabolic Syndrome
Recent studies have demonstrated that RAS inhibitors/calcium channel blockers are superior to
 RAS inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. As such, RAS
 inhibitors/calcium channel blockers are recommended as first line combination treatment for
 hypertension. However, the mechanism for the superior efficacy of RAS inhibitors/calcium
 channel blockers are not well defined. This study will compare the efficacy of RAS
 inhibitors/calcium channel blockers vs RAS inhibitors/diuretics in terms of glucose tolerance
 and insulin resistance in hypertensive patients with metabolic syndrome. The primary endpoint
 will be that RAS inhibitors/calcium channel blockers will be more efficacious in reducing
 2hour post prandial glucose compared to RAS inhibitors/diuretics.
Inclusion Criteria:

 -  consent to the study

 -  Male or Female ≥ 20 years

 -  Patients taking less than 1 antihypertensive medications or not taking
 antihypertensive medications. Hypertension defined at the screening visit as follows):
 140mmHg < MSSBP or MSDBP > 90mmHg at screening

 -  Hypertensive patients with non diabetic metabolic syndrome will be enrolled. Metabolic
 syndrome is defined according to NCEP guideline. (3 or more than) ① Abdominal obesity:
 Waist circumference M ≥ 90cm, F ≥ 80cm

 ② Hypertriglyceridaemia: Triglycerides ≥ 150mg/dL

 ③ Low HDL cholesterol Men: HDL cholesterol ≤ 40mg/dL Women: HDL cholesterol ≤ 50mg/dL

 ④ Elevated blood pressure (systolic blood pressure ≥ 130 mmHg and diastolic blood
 pressure ≥ 85 mmHg, or current use of antihypertensive drugs)

 ⑤ Impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dL

 -  Patient not taking statin medication and if the patient had ate statin medication the
 last duration must be before 3 months.

 Exclusion Criteria:

 -  • Women of child-bearing potential without a contraceptive measure

 -  (Pregnant or nursing women

 -  Known or suspected contraindications: history of allergy or hypersensitivity

 -  History of clinically significant allergies including asthma and/or multiple drug
 allergies

 -  Patients taking more than 2 antihypertensive medications

 -  Patient taking statin medication and taking statin within 3 months

 -  MSSBP > 180 mmHg or MSDBP > 110 mmHg at any time during the study

 -  Evidence of a secondary form of hypertension)

 -  History of hypertensive encephalopathy, cerebrovascular accident, transient
 ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI)
 or coronary artery bypass graft surgery (CABG) for 12 months prior to Visit 1

 -  History of heart failure Grade II - IV according to the NYHA classification

 -  Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia

 -  Concomitant unstable angina pectoris

 -  Clinically significant valvular heart disease

 -  Patients with Type 1 or Type 2 diabetes mellitus

 -  Evidence of hepatic disease as determined by one of the following: AST or ALT
 values ≥ 3 x UNL, a history of hepatic encephalopathy, history of esophageal
 varices, or history of portocaval shunt

 -  Evidence of renal impairment as determined by one of the following: serum
 creatinine >2mg/dL , history of dialysis, or history of nephrotic syndrome

 -  Protein in U/A values 2+ ≤

 -  Serum potassium values < 3.2 or > 5.2 mmol/L

 -  History of malignancy of any organ system within the past 5 years, treated or
 untreated, including leukemia and lymphoma, as further defined in the full
 protocol

 -  Chronic use of NSAIDs

 -  Use of cyclooxygenase-2 inhibitors (COX-2 inhibitors

 -  Use of niacin > 100 mg/d

 -  Use of loop diuretics

 -  Use of statin shorter than 3 months

 -  Inability to discontinue prior antihypertensive drugs as specified in the full
 protocol

 -  persons directly involved in the execution of this protocol

 -  Volume depletion based on the investigator's clinical judgment using vital signs,
 skin turgor, moistness of mucous membranes, and laboratory values

 -  Any severe, life-threatening disease within the past five years