A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs combination therapy with an angiotensin II receptor antagonist and a calcium channel blocker in hypertensive patients with metabolic syndrome

UMIN ID: UMIN000001238

Registered date:10/07/2008

Basic Information

• Health condition(s) or Problem(s) studied: Hypertension with metabolic syndrome
• Date of first enrollment: 2007/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Losartan / HCTZ group
Losartan (50 mg) and amlodipine (5 mg) combination group

Outcome(s)

• Primary Outcome: Change in systolic blood pressure after 12 weeks of treatment
• Secondary Outcome: - Change and % change in blood pressure after 12 and 24 weeks of treatment (excluding change in systolic blood pressure after 12 weeks of treatment) - Change and % change in Adiponectin, 8OHdG, HOMA-R, microalbuminuria, hs-CRP after 12 and 24 weeks of treatment - Safety throughout the treatment period - For other laboratory test values, exploratory analysis is to be conducted to analyze variations within a group and/or between two groups.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male
• Exclude criteria: Exclusion criteria: 1) Patients with uncontrolled hypertension (diastolic blood pressure ≥ 110mmHg) 2) Patients with malignant hypertension 3) Patients with uncontrolled diabetes (HbA1c ≥8.0%) 4) Patients with uncontrolled hypertriglyceridemia (TG ≥400mg/dL) 5) Patients who have stroke, AMI and/or critical vascular complications that required hospitalization within 6 months prior to the intervention 6) Patients with liver dysfunction [GPT(ALT) over three times the normal value] 7) Patients with renal failure (serum creatinine ≥2.0 mg/dL) 8) Patients with a previous history of gout attack or uncontrolled hyperuricemia (≥8.0mg/dL) 9) Patients under treatment with insulin 10) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 11) Patients with uncontrolled arhythmia 12) Patients with severe valvular disease including mitral stenosis and incompetence of aortic valve 13) Patients with cardiac insufficiency (NYHA grade III or IV) 14) Patients with a history of hypersensitivity to ingredients of losartan potassium 15) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 16) Patients with a history of hypersensitivity to ingredients of dihydropyridines 17) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Related Information

• Primary Sponsor: Hypertension in Metabolic syndrome CHIBA (HMS-CHIBA) Study group
• Source(s) of Monetary Support: Japan Heart Foundation