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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: amlodipine/valsartan; Drug: hydrochlorothiazide/telmisartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01819220

4-2009-0077

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

amlodipine/valsartan

Active Comparator group

Treatment:

Drug: amlodipine/valsartan

hydrochlorothiazide/telmisartan

Experimental group

Treatment:

Drug: hydrochlorothiazide/telmisartan