Status:
COMPLETED
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
Lead Sponsor:
Yonsei University
Conditions:
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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/cal...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01819220
Start Date
April 1 2009
End Date
November 1 2014
Last Update
June 10 2015
Active Locations (1)
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1
Yonsei universty medical center
Seoul, Seoul, South Korea, 120-752