A comparison of a combination drug of an angiotensin II receptor antagonist and a low-dose diuretic vs. a high-dose angiotensin II receptor antagonist in hypertensive patients

UMIN ID: UMIN000001279

Registered date:01/08/2008

Basic Information

• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2008/03/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

losartan / HCTZ group
high-dose angiotensin II receptor antagonist group

Outcome(s)

• Primary Outcome: Change and % change in blood pressure after 3months of treatment
• Secondary Outcome: - Change and % change in serum uric acid and serum blood glucose level after 3, 6 and 12 months of treatment. - Change and % change in blood pressure after 6 and 12 months of treatment. - Change and % change in HbA1c, microalbuminuria and BNP after 6 and 12 months of treatment. - Safety throughout the treatment period

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients under treatment with diuretics 2) Patients with office systolic blood pressure ≥ 180mmHg or office diastolic blood pressure ≥ 110mmHg 3) Patients with malignant hypertension 4) Patients who have stroke, myocardial infarction or other critical vascular complications that required hospitalization within 6 months prior to informed consent 5) Patients with liver dysfunction (ALT [GOT] and/or AST [GPT] over three times the normal value) 6) Patients with renal failure (serum creatinine ≥2.0 mg/dL) 7) Patients with a gout attack or hyperuricemia (≥8.0mg/dL) 8) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period 9) Patients with uncontrolled arrhythmia 10) Patients with severe valvular disease including mitral stenosis and incompetence of aortic valve 11) Patients with cardiac insufficiency (NYHA grade III or IV) 12) Patients with a history of hypersensitivity to ingredients of losartan potassium 13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 14) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Related Information

• Primary Sponsor: Vascular Care Network (VCN) Kamanza study group
• Source(s) of Monetary Support: Japan Vascular Disease Research Foundation