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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yonsei University
• Treatments: Amlodipine; Amlodipine, Valsartan Drug Combination; Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination; Valsartan

Criteria

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