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

NCT ID: NCT01819220

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

amlodipine/valsartan

Group Type: ACTIVE_COMPARATOR

amlodipine/valsartan

Intervention Type: DRUG

This is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome.

Active group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.

When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.

hydrochlorothiazide/telmisartan

Group Type: EXPERIMENTAL

hydrochlorothiazide/telmisartan

Intervention Type: DRUG

When the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.

When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.

Interventions

amlodipine/valsartan

This is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome.

Active group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.

When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.

Intervention Type: DRUG

hydrochlorothiazide/telmisartan

When the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.

When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed.

Intervention Type: DRUG

Other Intervention Names

Starting dose of amlodipine 5mg/ valsartan 80mg; Telmisartan 40mg/hydrochlorothiazide 12.5mg

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei universty medical center

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2009-0077

Identifier Type: -

Identifier Source: org_study_id