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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

Phase 4
Completed
Conditions
Hypertension
Interventions
Drug: hydrochlorothiazide/telmisartan
Drug: amlodipine/valsartan
Registration Number
NCT01819220
Lead Sponsor
Yonsei University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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.

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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
hydrochlorothiazide/telmisartanhydrochlorothiazide/telmisartan-
amlodipine/valsartanamlodipine/valsartan-
Primary Outcome Measures
NameTimeMethod
To assess the glucose changeTo assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yonsei universty medical center

🇰🇷

Seoul, Korea, Republic of

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