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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

Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: amlodipine/valsartan (Drug); hydrochlorothiazide/telmisartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Yonsei University

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: To assess the glucose change

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Yonsei universty medical center, Seoul 120-752, Korea, Republic of
Additional Information

Starting date: April 2009
Last updated: June 9, 2015

Page last updated: August 23, 2015

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