A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients

UMIN ID: UMIN000001389

Registered date:30/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2008/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Losartan/hydrochlorothiazide group
High-dose ARB group

Outcome(s)

• Primary Outcome: Change in blood pressure level measured on an outpatient basis after 12 weeks of treatment
• Secondary Outcome: - Change in blood pressure level measured on an outpatient basis after 24,48 weeks of treatment- Changes in blood pressure level at home after getting up,ABPM,NT-proBNP,hs-CRP,PAI-1,Aldosterone after 12, 24 and 48 weeks of treatment- Change in catroid internal-medical thickness after 48 weeks of treatment

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion criteria:1) Patients with uncontrolled hypertension (diastolic blood pressure under 110mmHg) 2) Patients with secondary hypertension 3) Patients with uncontrolled diabetes (HbA1c over 8.0%) and under treatment with insulin 4) Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 3 months prior to the intervention 5) Patients with liver dysfunction [GPT(ALT) over three times the normal value]6) Patients with renal failure (serum creatinine over 2.0 mg/dL)7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (over 8.0mg/dL)8) Patients with cardiac insufficiency (NYHA grade III )9) Patients with severe malignant cancer or other unfavorable prognostic factors10) Pregnant or possible pregnant women11) Patients , who have been previously treated with diuretics 12) Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics13) Patients with a history of hypersensitivity to ingredients of a calcium channel blocker to be used in the study14) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Related Information

• Primary Sponsor: Kobe hypertensive study group
• Source(s) of Monetary Support: The Waksman Foundation of Japan Inc.